Medical device registration holder
Roche Pakistan Ltd.
405 DRAP registrations and enlistments (1 Class , 119 Class A, 107 Class B, 151 Class C, 27 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Roche Pakistan Ltd.
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0000188 | Cobas 6800/8800 MPX Kit | D | Renewal passed |
| MDIR-0000184 | Cobas AmpliPrep/ Cobas TaqMan HCV Qualitative Test, v2.0 | D | Renewal passed |
| MDIR-0000190 | Cobas AmpliPrep/ Cobas TaqMan HIV-1 Qualitative Test, v2.0 | D | Renewal passed |
| MDIR-0000187 | Cobas AmpliPrep/Cobas Taqman HCV Quantitative Test, v2.0 | D | Renewal passed |
| MDIR-0009309 | Cobas CHIKV/DENV | D | Valid to May 2030 |
| MDIR-0000191 | Cobas Elecsys Anti-HBc IgM Kit | D | Renewal passed |
| MDIR-0000189 | Cobas Elecsys Anti-HBe Kit | D | Renewal passed |
| MDIR-0000193 | Cobas Elecsys Anti-HBs Kit | D | Renewal passed |
| MDIR-0000192 | Cobas Elecsys HBeAg Kit | D | Renewal passed |
| MDIR-0009607 | Cobas HEV - 192 [CAT # 09040986190, 192 Tests] | D | Valid to Jul 2030 |
| MDIR-0009606 | Cobas HEV Control Kit [CAT # 09040889190, 16 Kits] | D | Valid to Jul 2030 |
| MDIR-0003361 | Cobas HIV-1/HIV-2 Qualitative (Kit) | D | Valid to Apr 2027 |
| MDIR-0009608 | Cobas Malaria - 192 [CAT # 09352511190, 192 Tests] | D | Valid to Jul 2030 |
| MDIR-0009609 | Cobas Malaria Control Kit [CAT # 09352520190, 4 Kits] | D | Valid to Jul 2030 |
| MDIR-0009308 | Cobas MPX | D | Valid to May 2030 |
| MDIR-0000185 | Cobas TaqScreen MPX Test Kit V 2.0 | D | Renewal passed |
| MDIR-0000040 | Elecsys Anti HCV II Kit | D | Renewal passed |
| MDIR-0009939 | Elecsys Anti-HBs III [09810471190 09810480190 09810501190] | D | Valid to Aug 2030 |
| MDIR-0006325 | Elecsys HBsAg Confirmatory Test | D | Valid to Feb 2029 |
| MDIR-0000038 | Elecsys HBsAg II Kit | D | Renewal passed |
| MDIR-0006817 | Elecsys HBsAg II quant II Test Kit | D | Valid to Apr 2029 |
| MDIR-0005580 | Elecsys HCV Duo (Kit for Hepatitis C Testing) | D | Valid to Sep 2028 |
| MDIR-0000039 | Elecsys HIV Kit | D | Renewal passed |
| MDIR-0004250 | Elecsys HTLV I/II Kit | D | Valid to Dec 2027 |
| MDIR-0005143 | IVD Test Kit of Cobas HIV 1 / HIV 2 Qual for 6800 and… | D | Valid to May 2028 |
| MDIR-0006326 | PreciControl HIV; HIV-2+GrpO | D | Valid to Feb 2029 |
| MDIR-0005581 | Roche Cobas Electrodes of 9180 analyzer (Tests for measurement of Electrolytes) | D | Valid to Sep 2028 |
| MDIR-0000914 | Accu-Chek Active Blood Sugar Testing Strips | C | Renewal passed |
| MDIR-0001062 | Accu-Chek Active Control [Cat No. 03146324195] | C | Renewal passed |
| MDIR-0000913 | Accu-Chek Active MG/DL Blood Sugar Monitoring System | C | Renewal passed |
| MDIR-0001063 | Accu-Chek Guide Control [Cat No. 07748906020] | C | Renewal passed |
| MDIR-0000915 | Accu-Chek Guide Kit mg/Dl | C | Renewal passed |
| MDIR-0005586 | Accu-Chek Guide Link mg/dl Kit (Blood Glucose monitoring System) | C | Valid to Sep 2028 |
| MDIR-0000909 | Accu-Chek Guide Test Strips | C | Renewal passed |
| MDIR-0000912 | Accu-Chek Inform II Test Strips | C | Renewal passed |
| MDIR-0001064 | Accu-Chek Instant Control [Cat No.07869525020] | C | Renewal passed |
| MDIR-0003705 | Accu-Chek Instant Kit mg/dL (Instant forward) | C | Valid to Aug 2027 |
| MDIR-0000916 | Accu-Chek Instant S mg/dL Set | C | Renewal passed |
| MDIR-0000910 | Accu-Chek Instant Test Strips | C | Renewal passed |
| MDIR-0009610 | Accu-Chek Instant Test Strips [CAT #: 07819366023, Pack size: 10 Tests. CAT #: 07819374023,… | C | Valid to Jul 2030 |
| MDIR-0004700 | Accu-Chek Linearity Test Kit. [05048010001] | C | Valid to Feb 2028 |
| MDIR-0001061 | Accu-Chek Performa Control [Cat No.04861736001] | C | Renewal passed |
| MDIR-0000917 | Accu-Chek Performa mg/dL Kit | C | Renewal passed |
| MDIR-0005402 | Accu-Chek Performa Set mg/dL [06988032020] | C | Valid to Aug 2028 |
| MDIR-0000911 | Accu-Chek Performa Test Strips | C | Renewal passed |
| MDIR-0004699 | Accu-Chek SugarView | C | Valid to Feb 2028 |
| MDIR-0005583 | ACCUTREND PLUS KIT mg/dl Codes: 05050472 Size: 1 unit | C | Valid to Sep 2028 |
| MDIR-0009321 | Anti-p40 (SP225) Rabbit Monoclonal Primary Antibody | C | Valid to May 2030 |
| MDIR-0006324 | Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody | C | Valid to Feb 2029 |
| MDIR-0006323 | Anti-Pan Keratin (AE1/AE3/PCK26) Primary antibody | C | Valid to Feb 2029 |
| MDIR-0006322 | BenchMark Special Stains AFB Staining Kit | C | Valid to Feb 2029 |
| MDIR-0001255 | CoaguChek aPTT Controls (Level 1 + 2) | C | Renewal passed |
| MDIR-0001260 | CoaguChek aPTT Test (Strips) | C | Renewal passed |
| MDIR-0001269 | CoaguChek INRange System | C | Renewal passed |
| MDIR-0001270 | CoaguChek Pro II (Coagulation Meter Kit) | C | Renewal passed |
| MDIR-0001257 | CoaguChek PT Controls (Level 1+2) | C | Renewal passed |
| MDIR-0001262 | CoaguChek PT Test (Strips) | C | Renewal passed |
| MDIR-0001259 | CoaguChek XS PT Controls | C | Renewal passed |
| MDIR-0001258 | CoaguChek XS PT Test (Strips) | C | Renewal passed |
| MDIR-0001261 | CoaguChek XS PT Test PST | C | Renewal passed |
| MDIR-0001256 | CoaguChek XS System | C | Renewal passed |
| MDIR-0004645 | Cobas 4800 CMV KIT | C | Valid to Feb 2028 |
| MDIR-0006636 | Cobas 4800 HPV Amplification / Detection Kit | C | Valid to Apr 2029 |
| MDIR-0000626 | COBAS AmpliPrep/COBAS TaqMan HBV Test Kit, version 2.0 | C | Renewal passed |
| MDIR-0000186 | Cobas AmpliPrep/Cobas Taqman HCV Quantitative Test, v2.0 | C | Renewal passed |
| MDIR-0000627 | COBAS AmpliPrep/COBASTaq Man HIV-1 Test Kit, version 2.0 | C | Renewal passed |
| MDIR-0004695 | Cobas BKV Kit | C | Valid to Feb 2028 |
| MDIR-0001244 | Cobas BRAF, Mutation Test | C | Renewal passed |
| MDIR-0001265 | Cobas Cardiac C-Reactive Protein (Latex) High Sensitive (CRPHS) Test Kit | C | Renewal passed |
| MDIR-0000197 | Cobas CK Kits | C | Renewal passed |
| MDIR-0004702 | Cobas CMV Kit | C | Valid to Feb 2028 |
| MDIR-0004249 | Cobas CT/NG Cobas CT/NG Positive Control Kit | C | Valid to Dec 2027 |
| MDIR-0003706 | Cobas D-D12 (Tina Quant D-Dimer Gen. 2) Kit | C | Valid to Aug 2027 |
| MDIR-0004447 | Cobas DNA Sample Preparation Kit [Size: 24 Tests Code: 05985536190] | C | Valid to Dec 2027 |
| MDIR-0004644 | Cobas EBV 5800/6800/8800 | C | Valid to Feb 2028 |
| MDIR-0001543 | Cobas EGFR Mutation Test V2 Kit | C | Renewal passed |
| MDIR-0000640 | Cobas Elecsys AFP test kit | C | Renewal passed |
| MDIR-0001252 | Cobas Elecsys Anti-HAV Test Kit | C | Renewal passed |
| MDIR-0001268 | Cobas Elecsys BRAHMS PCT IVD Test Kit | C | Renewal passed |
| MDIR-0000632 | Cobas Elecsys CA 125 II test kit | C | Renewal passed |
| MDIR-0000630 | Cobas Elecsys CA 15-3 II test kit | C | Renewal passed |
| MDIR-0000635 | Cobas Elecsys CA 19-9 test kit | C | Renewal passed |
| MDIR-0000631 | Cobas Elecsys CEA Kit | C | Renewal passed |
| MDIR-0000196 | Cobas Elecsys CK MB Kits | C | Renewal passed |
| MDIR-0000639 | Cobas Elecsys CMV IgG Test Kit | C | Renewal passed |
| MDIR-0001245 | Cobas Elecsys CMV IgM Test Kit | C | Renewal passed |
| MDIR-0001250 | Cobas Elecsys Cyclosporine Test Kit | C | Renewal passed |
| MDIR-0001247 | Cobas Elecsys Everolimus Test Kit | C | Renewal passed |
| MDIR-0001264 | Cobas Elecsys Free bhCG IVD Test Kit | C | Renewal passed |
| MDIR-0000634 | Cobas Elecsys free PSA test kit | C | Renewal passed |
| MDIR-0005584 | COBAS Elecsys HSV-2 IgG Test Kits [05572193190, 07027508190] | C | Valid to Sep 2028 |
| MDIR-0001251 | Cobas Elecsys PAPP-A Test Kit | C | Renewal passed |
| MDIR-0001266 | Cobas Elecsys PIGF Test Kit | C | Renewal passed |
| MDIR-0003707 | Cobas Elecsys PIVKA II Test Kit | C | Valid to Aug 2027 |
| MDIR-0000636 | Cobas Elecsys Rubella IgG Test Kit | C | Renewal passed |
| MDIR-0000633 | Cobas Elecsys Rubella IgM Test Kit | C | Renewal passed |
| MDIR-0001253 | Cobas Elecsys sFlt-1 Test Kit | C | Renewal passed |
| MDIR-0001249 | Cobas Elecsys Sirolimus Test Kit | C | Renewal passed |
| MDIR-0000629 | Cobas Elecsys Syphilis test kit | C | Renewal passed |
| MDIR-0001248 | Cobas Elecsys Tacrolimus Test Kit | C | Renewal passed |
| MDIR-0000628 | Cobas Elecsys Total PSA | C | Renewal passed |
| MDIR-0000637 | Cobas Elecsys TOXO IgG Test Kit | C | Renewal passed |
| MDIR-0000638 | Cobas Elecsys TOXO IgM Test Kit | C | Renewal passed |
| MDIR-0000195 | Cobas Elecsys Troponin / Cobas Roche Cardiac Assay | C | Renewal passed |
| MDIR-0000194 | Cobas Elecsys Troponin I IVD Test Kit | C | Renewal passed |
| MDIR-0004464 | COBAS Elecsys Troponin T HS Test Kit. | C | Valid to Dec 2027 |
| MDIR-0001254 | Cobas Elecys AntiHAV IgM Test Kit | C | Renewal passed |
| MDIR-0000622 | Cobas HBV Quantitative nucleic acid test kit (for use on the Cobas 6800/8800 Systems) | C | Renewal passed |
| MDIR-0000619 | cobas HBV Quantitative nucleic acid test kit. (For use on the Cobas 4800 System) | C | Renewal passed |
| MDIR-0000624 | Cobas HCV GT test kit (for use on the Cobas 4800 System) | C | Renewal passed |
| MDIR-0000621 | Cobas HCV Quantitative nucleic acid test kit (for use on Cobas 6800/8800 systems) | C | Renewal passed |
| MDIR-0000625 | Cobas HCV quantitative nucleic acid test kit (for use on the Cobas 4800 System) | C | Renewal passed |
| MDIR-0004458 | Cobas HCV Quantitative Nucleic acid test kit. | C | Valid to Dec 2027 |
| MDIR-0004248 | Cobas HIV-1 (Cobas 6800) Cobas NHP Negative Control Kit | C | Valid to Dec 2027 |
| MDIR-0000623 | Cobas HIV-1 quantitative nucleic acid test kit (for use on the Cobas 4800 System) | C | Renewal passed |
| MDIR-0000620 | cobas HIV-1 Quantitative nucleic acid test kit (for use on the Cobas 6800/8800 Systems) | C | Renewal passed |
| MDIR-0001263 | Cobas Homocysteine Enzymatic Assay Test Kit | C | Renewal passed |
| MDIR-0006637 | Cobas HPV | C | Valid to Apr 2029 |
| MDIR-0001542 | Cobas Kras Test Kit | C | Renewal passed |
| MDIR-0006320 | Cobas MTB | C | Valid to Feb 2029 |
| MDIR-0009307 | Cobas MTB-RIF/INH | C | Valid to May 2030 |
| MDIR-0004441 | Cobas NHP Negative Control Kit [Code: 07002220190] | C | Valid to Dec 2027 |
| MDIR-0009605 | Cobas PIK3CA Mutation Test | C | Valid to Jul 2030 |
| MDIR-0000198 | Cobas Roche Cardiac ProBNP Kit | C | Renewal passed |
| MDIR-0006810 | Cobas Salicylate (SALI) Test Kit | C | Valid to Apr 2029 |
| MDIR-0001940 | Cobas SARS-CoV-2 Kit (Real Time PCR) | C | Renewal passed |
| MDIR-0005579 | Cobas SARS-CoV-2 LIAT (Kit for Covid Test) | C | Valid to Sep 2028 |
| MDIR-0001267 | Cobas Tina-Quant D-Dimer Test Kit | C | Renewal passed |
| MDIR-0006321 | Confirm Anti-P53 (DO-7) Primary Antibody | C | Valid to Feb 2029 |
| MDIR-0009304 | Elecsys AFP | C | Valid to May 2030 |
| MDIR-0006819 | Elecsys AFP-L3 Test Kit | C | Valid to Apr 2029 |
| MDIR-0009311 | Elecsys AMH Plus Test Kit | C | Valid to May 2030 |
| MDIR-0003106 | Elecsys Anti SARS-CoV 2 S Test Kit (Anti Body Kit) | C | Valid to Jan 2027 |
| MDIR-0002415 | Elecsys Anti SARS-CoV-2 Test Kit (Antibody Kit) | C | Renewal passed |
| MDIR-0009318 | Elecsys Anti-HAV IgM | C | Valid to May 2030 |
| MDIR-0009313 | Elecsys Anti-HEV IgG Test Kit | C | Valid to May 2030 |
| MDIR-0009312 | Elecsys Anti-HEV IgM Test Kit | C | Valid to May 2030 |
| MDIR-0006815 | Elecsys Anti-p53 Test Kit | C | Valid to Apr 2029 |
| MDIR-0009319 | Elecsys CA 125 II | C | Valid to May 2030 |
| MDIR-0009302 | Elecsys CA 15-3 II | C | Valid to May 2030 |
| MDIR-0006634 | Elecsys CA 72-4 | C | Valid to Apr 2029 |
| MDIR-0009611 | Elecsys CA 72-4 [CAT #: 09744525190 Pack size: 100 Tests CAT #: 09005706214 Pack… | C | Valid to Jul 2030 |
| MDIR-0009873 | Elecsys CEA [CAT #: 09755616190 Pack size: 100 Tests CAT #: 04491777190 Pack size:… | C | Valid to Jul 2030 |
| MDIR-0006816 | Elecsys Chagas Test Kit | C | Valid to Apr 2029 |
| MDIR-0006818 | Elecsys CMV IgG Avidity Test Kit | C | Valid to Apr 2029 |
| MDIR-0006809 | Elecsys Cyfra 21-1 Test Kit | C | Valid to Apr 2029 |
| MDIR-0009876 | Elecsys free PSA [CAT #: 09744908190 Pack size: 100 Tests CAT #: 08828610214 Pack… | C | Valid to Jul 2030 |
| MDIR-0006812 | Elecsys GDF-15 Test Kit | C | Valid to Apr 2029 |
| MDIR-0009305 | Elecsys HCG+B | C | Valid to May 2030 |
| MDIR-0004697 | Elecsys HE4 | C | Valid to Feb 2028 |
| MDIR-0001246 | Elecsys HSV-1 IgG Test Kit | C | Renewal passed |
| MDIR-0006820 | Elecsys Myoglobin Test Kit | C | Valid to Apr 2029 |
| MDIR-0006821 | Elecsys NSE Test Kit | C | Valid to Apr 2029 |
| MDIR-0009879 | Elecsys PIVKA-II [CAT #: 09652043190 Pack size: 100 Tests] | C | Valid to Jul 2030 |
| MDIR-0009316 | Elecsys proBNP II | C | Valid to May 2030 |
| MDIR-0006190 | Elecsys proGRP | C | Valid to Jan 2029 |
| MDIR-0009878 | Elecsys Rubella IgM [CAT #: 09755837190 Pack size: 100 Tests] | C | Valid to Jul 2030 |
| MDIR-0006635 | Elecsys S100 | C | Valid to Apr 2029 |
| MDIR-0003107 | Elecsys SARS-CoV-2 Antigen Test Kit | C | Valid to Jan 2027 |
| MDIR-0006814 | Elecsys SCC Test Kit | C | Valid to Apr 2029 |
| MDIR-0009303 | Elecsys total PSA | C | Valid to May 2030 |
| MDIR-0006813 | Elecsys Toxo IgG Avidity Test Kit | C | Valid to Apr 2029 |
| MDIR-0009881 | Elecsys Toxo IgM [CAT #: 09755861190 Pack size: 100 Tests] | C | Valid to Jul 2030 |
| MDIR-0009317 | Elecsys Troponin T hs | C | Valid to May 2030 |
| MDIR-0009877 | HSCRP [CAT #: 09188266190 Pack size: 250 Tests CAT #: 09188240190 Pack size: 300… | C | Valid to Jul 2030 |
| MDIR-0009320 | ISE Internal Standard Gen. 2 conc. | C | Valid to May 2030 |
| MDIR-0009314 | MTX (Methotrexate) | C | Valid to May 2030 |
| MDIR-0006811 | Mycophenolic acid (MPA) Test Kit | C | Valid to Apr 2029 |
| MDIR-0006327 | ONLINE TDM Theophylline (THEO2) | C | Valid to Feb 2029 |
| MDIR-0004642 | PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody [Code: 790-2991 05278368001] | C | Valid to Feb 2028 |
| MDIR-0009315 | Roche Cardiac POC NT-proBNP | C | Valid to May 2030 |
| MDIR-0003710 | Roche Creatine Kinase (Kit) | C | Valid to Aug 2027 |
| MDIR-0003709 | Roche Creatine Kinase-MB (Kit) | C | Valid to Aug 2027 |
| MDIR-0003190 | SARS CoV-2 Antigen Self Test Nasal [Roche Cat # 09445323077 Reference # 9901-NCOV-06G Pack… | C | Valid to Jan 2027 |
| MDIR-0003105 | SARS-CoV-2 Rapid Antibody Test (Device kit) | C | Valid to Jan 2027 |
| MDIR-0004247 | SARS-COV-2 Rapid Antigen Test (Device Kit) [Size: 25 tests Ref: 9901- NCOV-01G (Cat No:… | C | Valid to Dec 2027 |
| MDIR-0005585 | TINA-QUANT MYOGLOBIN GEN 2 (MYO2) IVD Kit | C | Valid to Sep 2028 |
| MDIR-0009521 | Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail | C | Valid to May 2030 |
| MDIR-0004445 | Accu-Chek FastClix Lancets [Code: 05981174001, 05981310001 Sizes: 102 Lancets, 24 Lancets] | B | Valid to Dec 2027 |
| MDIR-0004444 | Accu-Chek Safe T Pro Uno [Code: 05888662200 Size: 200 Lancets] | B | Valid to Dec 2027 |
| MDIR-0004443 | ACCU-CHEK SOFTCLIX LANCETS [Code: 03307484200 Size: 200 Lancets] | B | Valid to Dec 2027 |
| MDIR-0004452 | ACCUTREND Cluster of reagents | B | Valid to Dec 2027 |
| MDIR-0004623 | Alcian Blue Staining Kit [Code:Roche # (05279186001) Ventana # 860-002 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0004626 | Alcian Yellow Staining Kit [Code:Roche # (05279321001) Ventana # 860-017 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0004620 | Amplification Kit [Code: Roche # (05266114001) Ventana # 760-080 Size: 100 Tests] | B | Valid to Feb 2028 |
| MDIR-0008959 | BenchMark Special Stains AFB Staining Kit | B | Valid to Apr 2030 |
| MDIR-0008962 | C.f.a.s PUC | B | Valid to Apr 2030 |
| MDIR-0009522 | CD34 (QBEnd/10) Mouse Monoclonal Antibody [Roche CAT #: 05267323001, Ventana CAT #: 760-2620, Size:… | B | Valid to May 2030 |
| MDIR-0004440 | Cell Marque IHC Cluster | B | Valid to Dec 2027 |
| MDIR-0004705 | Cell Marque IHC Cluster 2 | B | Valid to Feb 2028 |
| MDIR-0004704 | Cell Marque IHC Cluster 3 | B | Valid to Feb 2028 |
| MDIR-0009950 | Cell Marque IHC Cluster 5 | B | Valid to Aug 2030 |
| MDIR-0004703 | Cell Marque IHC Cluster-4 | B | Valid to Feb 2028 |
| MDIR-0004701 | Cluster of Cobas Electrolyte Electrodes | B | Valid to Feb 2028 |
| MDIR-0009942 | Cluster of Elecsys Folate III | B | Valid to Aug 2030 |
| MDIR-0009941 | Cluster of LH Calset II and FSH Calset II | B | Valid to Aug 2030 |
| MDIR-0004643 | Cluster of Non-immunosuppressi ve (TDM) | B | Valid to Feb 2028 |
| MDIR-0009949 | Cluster of PTH and PTH STAT | B | Valid to Aug 2030 |
| MDIR-0004446 | CoaguChek SoftClix Lancet [Code: 03506509001 Size: 50 Lancets] | B | Valid to Dec 2027 |
| MDIR-0004451 | COBAS b 221 Cluster of Sensors & Reagents. | B | Valid to Dec 2027 |
| MDIR-0004480 | COBAS Cluster of Anemia Marker | B | Valid to Jan 2028 |
| MDIR-0004450 | COBAS Cluster of Electrolyte Reagents | B | Valid to Dec 2027 |
| MDIR-0004454 | Cobas Cluster of Endocrine Hormones | B | Valid to Dec 2027 |
| MDIR-0004481 | COBAS Cluster of Enzymes | B | Valid to Jan 2028 |
| MDIR-0004455 | COBAS Cluster of Lipoprotein | B | Valid to Dec 2027 |
| MDIR-0004456 | COBAS Cluster of Renal Metabolism Assays. | B | Valid to Dec 2027 |
| MDIR-0003212 | Cobas Elecsys Fertility Markers | B | Valid to Feb 2027 |
| MDIR-0002478 | COBAS Elecsys IgE-II (Allergy Panel). IVD-Cluster | B | Renewal passed |
| MDIR-0002475 | Cobas Elecsys Thyroid antibodies and Anti-CCP Cluster | B | Renewal passed |
| MDIR-0004448 | COBAS Electrodes and Reagents of b121 | B | Valid to Dec 2027 |
| MDIR-0004719 | COBAS IVD Cluster of Complement components | B | Valid to Feb 2028 |
| MDIR-0004709 | COBAS IVD Cluster of DAT Toxicology | B | Valid to Feb 2028 |
| MDIR-0004453 | Cobas IVD Cluster of Urine Strips (Substrate) | B | Valid to Dec 2027 |
| MDIR-0004691 | Cobas MTB Cluster | B | Valid to Feb 2028 |
| MDIR-0004442 | Cobas RheumatoidInflammatory Markers | B | Valid to Dec 2027 |
| MDIR-0004463 | COBAS Substrate Panel Products | B | Valid to Dec 2027 |
| MDIR-0002476 | Cobas Thyroid Cluster | B | Renewal passed |
| MDIR-0004449 | COBAS Tina Quant Immunoglobins | B | Valid to Dec 2027 |
| MDIR-0004637 | Congo Red Staining Kit [Code: Roche # (05279429001) Ventana # 860-026 Size: 40 Tests] | B | Valid to Feb 2028 |
| MDIR-0002474 | Diabetes Assay CPS (Centralized and Point of Care Testing Solutions) Cluster | B | Renewal passed |
| MDIR-0008960 | Diabetes Assay of CPS | B | Valid to Apr 2030 |
| MDIR-0004630 | Diastase Kit [Code:Roche # (05279208001) Ventana # 860-004 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0004631 | Elastic Staining Kit [Code:Roche # (05279216001) Ventana # 860-005 Size:75 Tests ] | B | Valid to Feb 2028 |
| MDIR-0004718 | Elecsys Active B12 assay | B | Valid to Feb 2028 |
| MDIR-0004711 | ELECSYS CALCITONIN | B | Valid to Feb 2028 |
| MDIR-0009948 | Elecsys Cortisol III | B | Valid to Aug 2030 |
| MDIR-0009947 | Elecsys Cortisol III Urine Test Kit | B | Valid to Aug 2030 |
| MDIR-0008963 | Elecsys EBV | B | Valid to Apr 2030 |
| MDIR-0008965 | Elecsys EBV EBNA IgG | B | Valid to Apr 2030 |
| MDIR-0008964 | Elecsys EBV VCA IgG | B | Valid to Apr 2030 |
| MDIR-0004717 | Elecsys Epstein Barr virus (EBV) Products | B | Valid to Feb 2028 |
| MDIR-0009874 | Elecsys Ferritin [CAT #: 09755667190 Pack size: 100 Tests CAT #: 03737551214 Pack size:… | B | Valid to Jul 2030 |
| MDIR-0009946 | Elecsys IGFBP-3 | B | Valid to Aug 2030 |
| MDIR-0009945 | Elecsys IGFBP-3 Test Kit | B | Valid to Aug 2030 |
| MDIR-0008967 | Elecsys PTH | B | Valid to Apr 2030 |
| MDIR-0009880 | Elecsys SHBG [CAT #: 09744495190 Pack size: 100 Tests] | B | Valid to Jul 2030 |
| MDIR-0003213 | Elecsys Vitamin B12 and Vitamin D Test Kits | B | Valid to Feb 2027 |
| MDIR-0009875 | Elecsys Vitamin B12 II [CAT #: 09755896190 Pack size: 100 Tests CAT #: 07028121214… | B | Valid to Jul 2030 |
| MDIR-0004629 | Endogenous Biotin Blocking Kit [Code:Roche #(05266092001) Ventana # 760-050 Size: One Pack/250 Tests] | B | Valid to Feb 2028 |
| MDIR-0004624 | Giemsa Staining Kit [Code:Roche #(05279224001) Ventana # 860-006 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0004638 | GMS II Staining Kit [Code: Roche # (05412749001) Ventana # 860-028 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0005142 | Gram Staining Kit [Code:Roche # (06890105001) Ventana # 860-039 Size: 75 Tests] | B | Valid to May 2028 |
| MDIR-0004698 | INFORM EBER (Epstein-Barr Virus Early RNA) Probe [800-2842 Roche CAT # 05278660001 INFORM EBER… | B | Valid to Feb 2028 |
| MDIR-0004632 | Iron Staining Kit [Code:Roche # (05279259001) Ventana # 860-009 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0008961 | ISE Calibration Kit | B | Valid to Apr 2030 |
| MDIR-0004694 | ISH IVIEW BLUE DETECTION KIT [Code: 800-092 Roche Cat # 05278511001 Pack size: 200… | B | Valid to Feb 2028 |
| MDIR-0004621 | ISH iView Blue Plus Detection Kit [Code:Roche # (05266181001) Ventana # 760-097 Size: 100… | B | Valid to Feb 2028 |
| MDIR-0004710 | IVD CLUSTER OF ACETAMINOPHEN | B | Valid to Feb 2028 |
| MDIR-0004708 | IVD Cluster of Bone Markers | B | Valid to Feb 2028 |
| MDIR-0004714 | IVD Cluster of IHC Products (Breast Panel) | B | Valid to Feb 2028 |
| MDIR-0004706 | IVD Cluster of Non-immunosuppressi ve TDM 2 | B | Valid to Feb 2028 |
| MDIR-0004707 | IVD Cluster of Specific Proteins | B | Valid to Feb 2028 |
| MDIR-0004462 | IVD Cluster of Ventana IHC products (Detection Kits) | B | Valid to Dec 2027 |
| MDIR-0004460 | IVD Cluster of Ventana IHC Products (Gastrointestinal Panel) | B | Valid to Dec 2027 |
| MDIR-0004461 | IVD Cluster of Ventana IHC Products (Hemepath Panel) | B | Valid to Dec 2027 |
| MDIR-0005163 | IVD Cluster of Ventana IHC Products (Staining reagent) | B | Valid to May 2028 |
| MDIR-0004459 | IVD Test Kit of Tina-quant Cystatin C Gen2 (CYSC 2) | B | Valid to Dec 2027 |
| MDIR-0004635 | Jones Light Green Staining Kit [Code:Roche # (05279356001) Ventana # 860-020 Size: 40 Tests] | B | Valid to Feb 2028 |
| MDIR-0004627 | Jones Staining Kit [Code:Roche # (05279348001) Ventana # 860-019 Size: 40 Tests ] | B | Valid to Feb 2028 |
| MDIR-0004712 | MDN2 ONLINE DAT Methadone II IVD cluster of Urine strips (Substrate) | B | Valid to Feb 2028 |
| MDIR-0004633 | Mucicarmine Staining Kit [Code:Roche # (05279275001) Ventana # 860-011 Size:75 Tests] | B | Valid to Feb 2028 |
| MDIR-0004641 | OptiView Amplification Kit [Code (06396518001) Ventana # 760-099 Size:50 Tests] | B | Valid to Feb 2028 |
| MDIR-0004640 | OptiView DAB IHC Detection Kit [Code:(06396500001) Ventana # 760-700 Size:250 Tests] | B | Valid to Feb 2028 |
| MDIR-0004634 | PAS Staining Kit [Code:Roche # (05279291001) Ventana # 860-014 Size:75 Tests] | B | Valid to Feb 2028 |
| MDIR-0008966 | PCP (Phencyclidine Plus) | B | Valid to Apr 2030 |
| MDIR-0004636 | Reticulum II Staining Kit [Code:Roche # (05279399001) Ventana # 860-024 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0002477 | ROCHE COBAS ANTI HAV II IVD-Test kit | B | Renewal passed |
| MDIR-0004692 | Roche cobas b 123 Fluid Pack and Sensors | B | Valid to Feb 2028 |
| MDIR-0004721 | Roche cobas Calibrator for Automated System | B | Valid to Feb 2028 |
| MDIR-0004619 | Roche cobas Calibrator for Automated Systems | B | Valid to Feb 2028 |
| MDIR-0004720 | Roche Cobas Cluster of Transport Proteins | B | Valid to Feb 2028 |
| MDIR-0004716 | Roche Cobas Elecsys IL-6 Assay | B | Valid to Feb 2028 |
| MDIR-0004618 | Roche Cobas Elecsys IL-6 Assay cluster | B | Valid to Feb 2028 |
| MDIR-0004625 | Special Stains Cleaning Kit [Code:Roche # (05279313001) Ventana # 860-016 Size: 50 Tests] | B | Valid to Feb 2028 |
| MDIR-0004628 | Steiner II Staining Kit [Code:Roche # (06890105001) Ventana # 860-039 Size: 75 Tests] | B | Valid to Feb 2028 |
| MDIR-0009943 | STFR (Soluble Transferrin Receptor) | B | Valid to Aug 2030 |
| MDIR-0009944 | Tina-quant Lambda & Kappa Gen. 2 (Cluster of Immunoglobulin) | B | Valid to Aug 2030 |
| MDIR-0004622 | ultraVIEW SISH Detection Kit [Code: Roche # (05271967001) Ventana # 780-001 Size: 100 Tests] | B | Valid to Feb 2028 |
| MDIR-0004639 | ultraView Universal Alkaline Phosphatase Red Detection Kit [Code (05269814001) Ventana # 760-501 Size: 250… | B | Valid to Feb 2028 |
| MDIR-0004457 | Ventana CONFIRM IVD Cluster of IHC Products (Breast Panel) | B | Valid to Dec 2027 |
| MDIR-0004693 | VENTANA IHC PRODUCTS (GI PANEL) | B | Valid to Feb 2028 |
| MDIR-0004715 | Ventana IVD Cluster of IHC Products (Dermatology Panel) | B | Valid to Feb 2028 |
| MDIR-0004713 | Ventana IVD Cluster of IHC Products (Lung Panel) | B | Valid to Feb 2028 |
| MDIR-0004696 | VENTANA IVD Cluster of Prostate Panel | B | Valid to Feb 2028 |
| MDIR-0004722 | VENTANA IVD Cluster of Prostate Panel | B | Valid to Feb 2028 |
| MDIE-0000622 | 9180 Electrolyte Analyzer [03157334001 Size: 1 Unit] | A | Valid to Feb 2028 |
| MDIE-0000730 | Accu-Chek Inform II (System for Blood Glucose monitoring) | A | Valid to Sep 2028 |
| MDIE-0001643 | B-Gate Interface | A | Valid to Apr 2030 |
| MDIE-0001964 | BenchMark GX | A | Valid to May 2030 |
| MDIE-0001965 | BenchMark GX AFM 120V Assembly | A | Valid to May 2030 |
| MDIE-0001966 | BenchMark GX AFM 230V Assembly | A | Valid to May 2030 |
| MDIE-0001634 | BenchMark Special Stains Cleaning Kit | A | Valid to Apr 2030 |
| MDIE-0000699 | BenchMark XT System with accessories | A | Valid to Jun 2028 |
| MDIE-0001648 | CCM Address Extension Unit | A | Valid to Apr 2030 |
| MDIE-0001633 | Cell Conditioning Solution (CC2) | A | Valid to Apr 2030 |
| MDIE-0000632 | Cell-Free DNA Collection Tube | A | Valid to Feb 2028 |
| MDIE-0001649 | Chimney for Cobas C111 Analyzer | A | Valid to Apr 2030 |
| MDIE-0000639 | Cobas 4800 system [Generic reagents] | A | Valid to Feb 2028 |
| MDIE-0001640 | Cobas 4800 system Control Diluent Kit | A | Valid to Apr 2030 |
| MDIE-0001639 | Cobas 4800 system Liquid Cytology Preparation Kit | A | Valid to Apr 2030 |
| MDIE-0001638 | Cobas 4800 system sample Preparation Kit | A | Valid to Apr 2030 |
| MDIE-0001641 | Cobas 4800 system Wash Buffer Kit | A | Valid to Apr 2030 |
| MDIE-0000637 | Cobas 4800 Systems | A | Valid to Feb 2028 |
| MDIE-0000638 | cobas 5800 System | A | Valid to Feb 2028 |
| MDIE-0000600 | Cobas 6000 Analyzer series (system) | A | Valid to Dec 2027 |
| MDIE-0000701 | Cobas 6500 Installation Kit for LAS [Code: 07438451001 Cobas 6500 Installation Kit for LAS… | A | Valid to Jun 2028 |
| MDIE-0000643 | Cobas 6500 System | A | Valid to Feb 2028 |
| MDIE-0000598 | Cobas 6800 system | A | Valid to Dec 2027 |
| MDIE-0001650 | Cobas 8000 A-Gate Connection Kit | A | Valid to Apr 2030 |
| MDIE-0001653 | Cobas 8000 B-Gate Kit | A | Valid to Apr 2030 |
| MDIE-0000640 | Cobas Ampliprep system | A | Valid to Feb 2028 |
| MDIE-0000627 | Cobas b 101 system [06378668190 Pack size: One Unit] | A | Valid to Feb 2028 |
| MDIE-0000599 | Cobas b 121 system | A | Valid to Dec 2027 |
| MDIE-0000641 | Cobas b 123 POC System | A | Valid to Feb 2028 |
| MDIE-0001678 | Cobas b221 system | A | Valid to Apr 2030 |
| MDIE-0001677 | Cobas b221 system | A | Valid to Apr 2030 |
| MDIE-0001644 | Cobas Bulk Loader Input Module (BLIM) | A | Valid to Apr 2030 |
| MDIE-0000604 | Cobas C111 Analyzer (Without ISE) | A | Valid to Dec 2027 |
| MDIE-0000601 | Cobas c311 Analyzer with IVD consumables | A | Valid to Dec 2027 |
| MDIE-0000710 | Cobas e411 Analyzer with accessories | A | Valid to Jun 2028 |
| MDIE-0000642 | COBAS h 232 ANALYZER WITH ACCESSORIES | A | Valid to Feb 2028 |
| MDIE-0000634 | cobas LIAT System [07341920190 Size: 1 Unit] | A | Valid to Feb 2028 |
| MDIE-0000625 | Cobas Omni Utility Channel Reagent Kit [09052011190] | A | Valid to Feb 2028 |
| MDIE-0000630 | Cobas p 312 pre-analytical system [06459315001] | A | Valid to Feb 2028 |
| MDIE-0001937 | cobas p 471 centrifuge unit [07962584001] | A | Valid to May 2030 |
| MDIE-0001938 | Cobas p 471 centrifuge unit [07962606001] | A | Valid to May 2030 |
| MDIE-0001939 | Cobas p 471 centrifuge unit [08484346001] | A | Valid to May 2030 |
| MDIE-0001940 | Cobas p 471 centrifuge unit [08484554001] | A | Valid to May 2030 |
| MDIE-0001930 | Cobas p 512 pre-analytical system [07962649001] | A | Valid to May 2030 |
| MDIE-0001931 | Cobas p 512 pre-analytical system [07962657001] | A | Valid to May 2030 |
| MDIE-0001928 | Cobas p 512 pre-analytical system [08479763001] | A | Valid to May 2030 |
| MDIE-0001929 | Cobas p 512 pre-analytical system [08479771001] | A | Valid to May 2030 |
| MDIE-0001932 | Cobas p 512 pre-analytical system [09639900001] | A | Valid to May 2030 |
| MDIE-0001933 | Cobas p 512 pre-analytical system [09639918001] | A | Valid to May 2030 |
| MDIE-0001934 | Cobas p 512 pre-analytical system [09639926001] | A | Valid to May 2030 |
| MDIE-0001935 | Cobas p 512 pre-analytical system [09639934001] | A | Valid to May 2030 |
| MDIE-0000706 | Cobas p 512 pre-analytical unit | A | Valid to Jun 2028 |
| MDIE-0000711 | Cobas p 612 pre-analytical system | A | Valid to Jun 2028 |
| MDIE-0001941 | Cobas p 612 pre-analytical system [07962665001] | A | Valid to May 2030 |
| MDIE-0001942 | Cobas p 612 pre-analytical system [07962673001] | A | Valid to May 2030 |
| MDIE-0001943 | Cobas p 612 pre-analytical system [07962703001] | A | Valid to May 2030 |
| MDIE-0001946 | Cobas p 612 pre-analytical system [09639942001] | A | Valid to May 2030 |
| MDIE-0001947 | Cobas p 612 pre-analytical system [09639969001] | A | Valid to May 2030 |
| MDIE-0001944 | Cobas p 612 pre-analytical system [09639977001] | A | Valid to May 2030 |
| MDIE-0001945 | Cobas p 612 pre-analytical system [09639985001] | A | Valid to May 2030 |
| MDIE-0001925 | Cobas p 671 centrifuge unit [07962614001] | A | Valid to May 2030 |
| MDIE-0001926 | Cobas p 671 centrifuge unit [07962622001] | A | Valid to May 2030 |
| MDIE-0001927 | Cobas p 671 centrifuge unit [08484635001 | A | Valid to May 2030 |
| MDIE-0000629 | Cobas p 701 Post Analytics Unit | A | Valid to Feb 2028 |
| MDIE-0000626 | Cobas p501 post-analytical unit [05158494001] | A | Valid to Feb 2028 |
| MDIE-0000602 | Cobas PCR Media Dual Swab Sample Kit [Cobas PCR Media Dual Swab Sample Kit… | A | Valid to Dec 2027 |
| MDIE-0001637 | Cobas PCR Media Kit | A | Valid to Apr 2030 |
| MDIE-0000628 | Cobas PCR Urine | A | Valid to Feb 2028 |
| MDIE-0001628 | Cobas Plasma Separation Card | A | Valid to Apr 2030 |
| MDIE-0000636 | Cobas Plasma Separation Card [Code: 07963084190 Size: 450 Cards] | A | Valid to Feb 2028 |
| MDIE-0000633 | Cobas Plasma Separation Card [Size: 450 Cards] | A | Valid to Feb 2028 |
| MDIE-0001652 | Cobas pro B-Gate update kit | A | Valid to Apr 2030 |
| MDIE-0001651 | Cobas pro B-Gate upgrade kit | A | Valid to Apr 2030 |
| MDIE-0000669 | Cobas Pure system | A | Valid to May 2028 |
| MDIE-0000854 | Cobas Specimen Pre-Extraction Reagent | A | Valid to Sep 2029 |
| MDIE-0000631 | Cobas Specimen Pre-Extraction Reagent [Cobas PCR Urine Sample Kit Code:05170486190 Size: 100 Packets] | A | Valid to Feb 2028 |
| MDIE-0000623 | Cobas TaqScreen Wash Reagent [04404220190] | A | Valid to Feb 2028 |
| MDIE-0000707 | Cobas z 480 Analytical unit | A | Valid to Jun 2028 |
| MDIE-0002170 | ConKit Cobas BLIM [1. ConKit Cobas BLIM to p x71 CAT # 09523901001 Size:… | A | Valid to Aug 2030 |
| MDIE-0001936 | ConKit Cobas BLIM to p x71 | A | Valid to May 2030 |
| MDIE-0001676 | Cuvette Cobas Integra | A | Valid to Apr 2030 |
| MDIE-0001856 | DIBU (Dibucaine) | A | Valid to Apr 2030 |
| MDIE-0001951 | Digital LightCycler 5x DNA Master [09393544001] | A | Valid to May 2030 |
| MDIE-0001952 | Digital LightCycler 5x RNA Master [08897115001] | A | Valid to May 2030 |
| MDIE-0001948 | Digital LightCycler Analyzer [09274804001] | A | Valid to May 2030 |
| MDIE-0001954 | Digital LightCycler High Resolution Nanowell Plate [09033700001] | A | Valid to May 2030 |
| MDIE-0001955 | Digital LightCycler High Sensitivity Nanowell Plate [09033718001] | A | Valid to May 2030 |
| MDIE-0001949 | Digital LightCycler Partitioning Engine [09224777001] | A | Valid to May 2030 |
| MDIE-0001950 | Digital LightCycler Partitioning Fluid [08861536001] | A | Valid to May 2030 |
| MDIE-0001953 | Digital LightCycler Universal Nanowell Plate [09033696001] | A | Valid to May 2030 |
| MDIE-0001646 | Diluent AFP-L3 | A | Valid to Apr 2030 |
| MDIE-0001675 | Diluent MultiAssay | A | Valid to Apr 2030 |
| MDIE-0001645 | Diluent NSE | A | Valid to Apr 2030 |
| MDIE-0002011 | ECO-D (EcoTergent) [CAT #: 08063354190, 40ml] | A | Valid to May 2030 |
| MDIE-0001635 | Elastic Stain Core Kit | A | Valid to Apr 2030 |
| MDIE-0001627 | HybReady Solution | A | Valid to Apr 2030 |
| MDIE-0001647 | Internal Standard Insert - ISE | A | Valid to Apr 2030 |
| MDIE-0000700 | IVD BenchMark Special Stains | A | Valid to Jun 2028 |
| MDIE-0000603 | IVD Instrument BenchMark Ultra System with Accessories | A | Valid to Dec 2027 |
| MDIE-0000708 | IVD System of Cobas b221 Analyzer with accessories | A | Valid to Jun 2028 |
| MDIE-0000698 | MagNA Pure 24 System | A | Valid to Jun 2028 |
| MDIE-0001642 | MagNA Pure 24 Total NA Isolation Kit | A | Valid to Apr 2030 |
| MDIE-0000635 | Nozzle Tip 2000/Aliquot Tips 2000 [Code: 11996436001 Size: 4000 tips] | A | Valid to Feb 2028 |
| MDIE-0001673 | OptiView Amplification Kit | A | Valid to Apr 2030 |
| MDIE-0000624 | PYP (Pyridoxal Phosphate) [08062986190 Size: 950 Tests ] | A | Valid to Feb 2028 |
| MDIE-0001855 | Roche Cell Collection Medium Kit | A | Valid to Apr 2030 |
| MDIE-0001629 | Sample Cleaner 1 | A | Valid to Apr 2030 |
| MDIE-0001636 | Special Stains Van Gieson CS | A | Valid to Apr 2030 |
| MDIE-0002123 | SSR Solution [CAT # 06890059001 Pack size: 2 L] | A | Valid to Jul 2030 |
| MDIE-0000705 | TIP CORE (HAMILTON) (Filter) | A | Valid to Jun 2028 |
| MDIE-0001674 | Trichrome Staining Kit | A | Valid to Apr 2030 |
| MDIE-0000709 | U411 Urine Analyzer | A | Valid to Jun 2028 |
| MDIE-0001626 | UCM2 Universal Connection Module to CCM | A | Valid to Apr 2030 |
| MDIE-0001632 | UltraView Silver Wash II | A | Valid to Apr 2030 |
| MDIE-0000644 | URISYS 1100 KIT INTERNATIONAL | A | Valid to Feb 2028 |
| MDIE-0001232 | Ventana DP 200 slide scanner | A | Valid to Apr 2030 |
| MDIE-0001672 | Ventana DP 600 slide Scanner | A | Valid to Apr 2030 |
| MDIE-0001631 | Ventana Red ISH DIG Detection Kit | A | Valid to Apr 2030 |
| MDIE-0001630 | Ventana Silver ISH DNP Detection Kit | A | Valid to Apr 2030 |
| MDIR-0009940 | Elecsys Androstenedione | Valid to Aug 2030 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.