Medical device registration holder
Global Marketing Services
229 DRAP registrations and enlistments (37 Class A, 42 Class B, 73 Class C, 77 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Global Marketing Services
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0000590 | ADROIT Guiding Catheters | D | Renewal passed |
| MDIR-0003088 | Aptima HCV Quant Dx Assay kit | D | Valid to Dec 2026 |
| MDIR-0003089 | Aptima HIV-1 Quant Dx Assay kit | D | Valid to Dec 2026 |
| MDIR-0005056 | Assurity Pulse Generator | D | Valid to Apr 2028 |
| MDIR-0000315 | ATW Steerable Guidewires | D | Renewal passed |
| MDIR-0004601 | BI-PAL Biopsy Forceps [502-400B, 502-402B 502-402M] | D | Valid to Feb 2028 |
| MDIR-0003942 | Cordis Biopsy Forceps (standard, disposable) [504-300 5.5F Disposable Biopsy Forceps 104cm 504-302 5.5F Disposable… | D | Valid to Nov 2027 |
| MDIR-0003938 | CORDIS Long Sheath. (Long Sheath Set) [501-610, 501-611, 501-612, 501-613, 501-611A, 601-613A, 501-616A, 501-617] | D | Valid to Nov 2027 |
| MDIR-0000517 | CPD Adenine Grifols (Blood Bags containing anti-coagulant Citrate Phosphate Dextrose Adenine) | D | Renewal passed |
| MDIR-0005854 | CPS Aim SL (Slittable inner catheter) | D | Valid to Dec 2028 |
| MDIR-0005855 | CPS Direct PL (Peelable Outer Guide Catheter) | D | Valid to Dec 2028 |
| MDIR-0007631 | CPS Locator TM 3D Delivery System [Single Use Percutaneous Delivery System] | D | Valid to Jan 2030 |
| MDIR-0005059 | Durata Defibrillation Leads | D | Valid to Apr 2028 |
| MDIR-0002766 | EIAgen HBsAg Kit (EIAgen Detect HIV 4 total Screening Kit) | D | Renewal passed |
| MDIR-0000548 | EIAgen HCV Ab (v.4) (HCV Ab-Hepatitis C Virus Antibody) test kit | D | Renewal passed |
| MDIR-0005057 | Ellipse Implantable Cardioverter Defibrillator | D | Valid to Apr 2028 |
| MDIR-0000314 | Emerald Diagnostic Guidewire | D | Renewal passed |
| MDIR-0005054 | Endurity Core Pulse Generator | D | Valid to Apr 2028 |
| MDIR-0005055 | Endurity MRI PULSE GENERATOR | D | Valid to Apr 2028 |
| MDIR-0002510 | Enticos 4 D (Dual Chamber Pacemaker-MR Conditional) (with accessories) Code: 407156 | D | Renewal passed |
| MDIR-0002116 | Enticos 4 DR [Dual Chamber Pacemaker-MR Conditional] (with accessories) Code: 407155 | D | Renewal passed |
| MDIR-0002511 | Enticos 4 S (Single Chamber Pacemaker-MR Conditional) (with accessories) Code: 407168 | D | Renewal passed |
| MDIR-0002509 | Enticos 4 SR (Single Chamber Pacemaker-MR Conditional) (with accessories) Code: 407167 | D | Renewal passed |
| MDIR-0005856 | Entrant ICD devices [CDDRA300Q] | D | Valid to Dec 2028 |
| MDIR-0006454 | Entrant ICD devices Entrant HF Code: CDHFA300Q | D | Valid to Mar 2029 |
| MDIR-0006453 | Entrant ICD devices Entrant VR Code: CDVRA300Q | D | Valid to Mar 2029 |
| MDIR-0005062 | Fortify Assura DR Implantable Cardioverter Defibrillator | D | Valid to Apr 2028 |
| MDIR-0005857 | Gallant ICD devices [CDDRA500Q] | D | Valid to Dec 2028 |
| MDIR-0006456 | Gallant ICD devices Gallant HF Code: CDHFA500Q | D | Valid to Mar 2029 |
| MDIR-0006455 | Gallant ICD devices Gallant VR Code: CDVRA500Q | D | Valid to Mar 2029 |
| MDIR-0000550 | HBV Real-TM Quant DX (HBV Hepatitis B Virus Quantitative) V5-96/3FRT | D | Renewal passed |
| MDIR-0000549 | HCV Real-TM Quant DX (HCV Hepatitis C Virus Quantitative) V1-96/3FRT | D | Renewal passed |
| MDIR-0000589 | High Flow Diagnostic Catheter | D | Renewal passed |
| MDIR-0000313 | IKAZUCHI Zero PTCA Balloon Dilatation Catheter | D | Renewal passed |
| MDIR-0000317 | INFINITI Diagnostic Catheter | D | Renewal passed |
| MDIR-0002677 | Inlexa 3 DR-T (Implantable cardioverter defibrillator-MR Conditional) (with accessories) [404701, 404702] | D | Renewal passed |
| MDIR-0002676 | Inlexa 3 HF-T (Implantable cardioverter defibrillator-MR Conditional) (with accessories) [404699, 404700, 416037, 416038] | D | Renewal passed |
| MDIR-0002675 | Inlexa 3 VR-T (Implantable cardioverter defibrillator-MR Conditional) (with accessories) [404703, 404704] | D | Renewal passed |
| MDIR-0000243 | Kaneka PTCA Catheter CO-R6, Raiden 3 | D | Renewal passed |
| MDIR-0002115 | Leucored Grifols CPD-SAG-M WB [Blood bags containing anti-coagulant] | D | Renewal passed |
| MDIR-0000585 | MAXI LD PTA Balloon Dialtation Catheter | D | Renewal passed |
| MDIR-0009487 | Merlin 2.0 Patient Care System Programmer (Programmer for cardiac implantable devices) | D | Valid to May 2030 |
| MDIR-0002734 | NEON NC PTCA Balloon Dilation Catheter (PTCA Balloon Dilation Catheter) | D | Renewal passed |
| MDIR-0002733 | NEON PTCA Balloon Dilation Catheter (PTCA balloon Dilation Catheter) | D | Renewal passed |
| MDIR-0000319 | Optease Retrievable Vena Cava Filter and Introduction Kit | D | Renewal passed |
| MDIR-0005858 | Peel-away Introducers | D | Valid to Dec 2028 |
| MDIR-0000588 | POWERFLEX PRO PTA Balloon Dilatation Catheter | D | Renewal passed |
| MDIR-0005061 | Quadra Allure Cardiac Resynchronization Therapy Pacemaker | D | Valid to Apr 2028 |
| MDIR-0005063 | Quadra Assura Cardiac Resynchronization Therapy Defibrillator | D | Valid to Apr 2028 |
| MDIR-0005058 | Quartet Left Heart Leads | D | Valid to Apr 2028 |
| MDIR-0007678 | Rapid Anti-HCV Test Anti-HCV Test Code:ITP01152-TC25 | D | Valid to Dec 2029 |
| MDIR-0007677 | Rapid Anti-HCV Test Anti-HCV Test Code:ITP01153-TC40 | D | Valid to Dec 2029 |
| MDIR-0003380 | Saber .035" Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | D | Valid to May 2027 |
| MDIR-0000587 | SABER PTA Balloon Dilatation Catheter | D | Renewal passed |
| MDIR-0007630 | SELUTION SLR 014 PTA Balloon Catheter (Invasive Balloon Catheter) | D | Valid to Jan 2030 |
| MDIR-0007629 | SELUTION SLR 018 PTA Balloon Catheter (Invasive Balloon Catheter) | D | Valid to Jan 2030 |
| MDIR-0000595 | SHINOBI Plus Steerable Guidewire | D | Renewal passed |
| MDIR-0000594 | SMART Control Nitinol Stent System | D | Renewal passed |
| MDIR-0000586 | SMART Flex Vascular Stent System | D | Renewal passed |
| MDIR-0000591 | SUPER Torque Angiographic Catheter | D | Renewal passed |
| MDIR-0001198 | SUPER Torque Plus Angiographic Catheter | D | Renewal passed |
| MDIR-0000592 | TEMPO Angiographic Catheter | D | Renewal passed |
| MDIR-0000593 | TEMPO AQUA Angiographic Catheter | D | Renewal passed |
| MDIR-0005060 | Tendrill STS Defibrillation Leads | D | Valid to Apr 2028 |
| MDIR-0000318 | Trapease Permanent Vena Cava Filter | D | Renewal passed |
| MDIR-0000558 | VIDAS anti-HCV HCV (Hepatitis C Virus) kit 30308 | D | Renewal passed |
| MDIR-0000557 | VIDAS HBs Ag Ultra HBsAg (Hepatitis B virus surface antigen) kit 30315 | D | Renewal passed |
| MDIR-0000559 | VIDAS HIV Duo Quick HIV (Human immunodeficiency virus) test kit 30447 | D | Renewal passed |
| MDIR-0000316 | VistaBriteTip Guiding Catheter | D | Renewal passed |
| MDIR-0001193 | Xpert HBV Viral Load (HBV VL) | D | Renewal passed |
| MDIR-0000513 | Xpert HCV Viral Load (HCV VL Hepatitis C Virus Viral Load) test kit GXHCV-VL-CE-10 | D | Renewal passed |
| MDIR-0003943 | Xpert HIV-1 Qual XC (HIV Detection Assay) | D | Valid to Nov 2027 |
| MDIR-0000512 | Xpert HIV-1 Viral Load (HIV-1 VL (Human immunodeficiency virus 1 Viral Load) test kit… | D | Renewal passed |
| MDIR-0009198 | Zenex MRI (Dual Chamber Inductive Pacemaker, MR Conditional) [PM2282] | D | Valid to Apr 2030 |
| MDIR-0009197 | Zenex MRI (Single Chamber Inductive Pacemaker, MR Conditional) [PM1282] | D | Valid to Apr 2030 |
| MDIR-0007626 | Zenus MRI (Dual Chamber Inductive Pacemaker, MR Conditional) [PM2182 (Dual Chamber Inductive Pacemaker, MR… | D | Valid to Jan 2030 |
| MDIR-0007625 | Zenus MRI (Single Chamber Inductive Pacemaker, MR Conditional) [PM1182 (Single Chamber Inductive Pacemaker, MR… | D | Valid to Jan 2030 |
| MDIR-0003635 | Amsco 600 (steam sterilizer and accessories) [Amsco 600] | C | Valid to Aug 2027 |
| MDIR-0002098 | API NH [Multiple Neisseria species culture isolate identification IVD] [10400 API NH] | C | Renewal passed |
| MDIR-0007714 | Aptima CMV Quant Assay (CMV Quantitative NAT Assay Kit) | C | Valid to Jan 2030 |
| MDIR-0007715 | Aptima Combo 2 Assay (Target amplification nucleic acid probe test, IVD qualitative detection kit) | C | Valid to Jan 2030 |
| MDIR-0003087 | Aptima HBV Quant Assay kit | C | Valid to Dec 2026 |
| MDIR-0003490 | Aptima HPV 16 18/45 Genotype Assay Kit | C | Valid to Jun 2027 |
| MDIR-0007552 | Aptima HPV Assay Kit [Aptima HPV Assay Tests: 100 Code: 302929] | C | Valid to May 2030 |
| MDIR-0005538 | Aptima SARS-CoV-2 assay PRD-06419 PRD-06420 SARS-CoV-2 detection assay | C | Valid to Sep 2028 |
| MDIR-0002505 | ARGENE SARSCOV-2 RESPI R-GENE Kit (Real Time Detection Kit) Code: 423732 | C | Renewal passed |
| MDIR-0002152 | ARGENE SARSCOV-2-GENE [Real Time Amplification and Detection Kit] | C | Renewal passed |
| MDIR-0005548 | BACT/ALERT BPA 279044 Culture Bottle | C | Valid to Sep 2028 |
| MDIR-0005549 | BACT/ALERT BPN 279045 Culture Bottle | C | Valid to Sep 2028 |
| MDIR-0003634 | BioFire Blood Culture Identification 2 (BCCID2) Panel (Bacterial/yeast nucleic acid detection Kit) | C | Valid to Aug 2027 |
| MDIR-0005542 | BioFire Joint Infection (JI) Panel RFIT-ASY-0138MB Multiplexed nucleic-acid assay | C | Valid to Sep 2028 |
| MDIR-0002773 | BioFire Respiratory Penel 2.1 Plus (RP 2.1 Plus) (Viral nucleic acid detection assay) [423740] | C | Renewal passed |
| MDIR-0000509 | FilmArray Meningitis/Encephalitis (ME) Panel | C | Renewal passed |
| MDIR-0000508 | FilmArray Pneumonia Panel plus (Test kit) | C | Renewal passed |
| MDIR-0009384 | Fluent Fluid Management System FLT-100 | C | Valid to May 2030 |
| MDIR-0009479 | Interlab Kit for Immunofixation | C | Valid to May 2030 |
| MDIR-0009480 | Intrerlab Kit for Serum Protein | C | Valid to May 2030 |
| MDIR-0002765 | Leica Bond IHC Reagents & Antibodies (Cancer Markers) [PA0424] | C | Renewal passed |
| MDIR-0009383 | NovaSure Impedance (Controlled Endometrial Ablation System) | C | Valid to May 2030 |
| MDIR-0001700 | OPTI Critical Care Analyzer (OPTI CCATS2) Part no: GD7046 | C | Renewal passed |
| MDIR-0000516 | Transfer Grifols (Transfer Blood Bags) | C | Renewal passed |
| MDIR-0003019 | V-PRO Max 2 Low Temperature Sterilization System [V-PRO Max 2] | C | Valid to Nov 2026 |
| MDIR-0004600 | V-PRO S2 Low Temperature Sterilization System and Accessories. (Hydrogen Peroxide Gas Sterilizer) | C | Valid to Feb 2028 |
| MDIR-0005539 | VeriSeq NIPT Solution v2 Non-invasive prenatal test | C | Valid to Sep 2028 |
| MDIR-0001187 | Vidas AFP (Alpha-fetoprotein) | C | Renewal passed |
| MDIR-0001192 | Vidas AMH (Anti-Mullerian Hormone) | C | Renewal passed |
| MDIR-0001185 | VIDAS anti HEV IgG (Hepatitis E virus immunoglobulin G (IgG) antibody IVD) | C | Renewal passed |
| MDIR-0001189 | VIDAS anti HEV IgM (Hepatitis E virus immunoglobulin M (IgM) antibody IVD) | C | Renewal passed |
| MDIR-0003016 | VIDAS Anti-Dengue IgG (DENG) Kit Code: 423079 [60 Tests] | C | Valid to Nov 2026 |
| MDIR-0003017 | VIDAS Anti-Dengue IgM (DENM) Kit Code: 423078 [60 Tests] | C | Valid to Nov 2026 |
| MDIR-0005544 | VIDAS C. difficile Toxin A & B 30118 C. difficile toxin A & toxin… | C | Valid to Sep 2028 |
| MDIR-0002663 | VIDAS CA 125 II (OC 125 antigenic detector) [Ref: 30426] | C | Renewal passed |
| MDIR-0002664 | VIDAS CA 15-3 (CA 15-3 levels detector) [Ref: 30429] | C | Renewal passed |
| MDIR-0002665 | VIDAS CA 19-9 (1116-NS-19-9 reactive antigenic determinants detector [Ref: 30427] | C | Renewal passed |
| MDIR-0002735 | VIDAS CEA (S) Kit Code: 30453 Size: 60 tests | C | Renewal passed |
| MDIR-0005546 | VIDAS CKMB 30421 MB isoenzyme (cardiac marker) detection kit | C | Valid to Sep 2028 |
| MDIR-0000552 | VIDAS CMV IGG (Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD 30204 | C | Renewal passed |
| MDIR-0000551 | VIDAS CMV IGM (Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD) 30205 | C | Renewal passed |
| MDIR-0002094 | VIDAS Cortisol S [30451] | C | Renewal passed |
| MDIR-0001190 | VIDAS D-Dimer Exclusion II (D-dimer IVD) | C | Renewal passed |
| MDIR-0003018 | VIDAS Dengue NS1 Ag (DEAG) Kit Code: 423077 [60 Tests] | C | Valid to Nov 2026 |
| MDIR-0002096 | VIDAS Ferritin [30411] | C | Renewal passed |
| MDIR-0005543 | VIDAS FPSA 30440 Prostate specific antigen (PSA) detection Kit | C | Valid to Sep 2028 |
| MDIR-0001864 | VIDAS HAV IgM Test Kit | C | Renewal passed |
| MDIR-0001186 | Vidas HCG (Total Human Chorionic gonadotropin) | C | Renewal passed |
| MDIR-0001191 | VIDAS High Sensitive Troponin I (Troponin I IVD) | C | Renewal passed |
| MDIR-0005545 | VIDAS NT-ProBNP2 30440 NT-ProBNP2 detection kit | C | Valid to Sep 2028 |
| MDIR-0000556 | VIDAS RUB IGG II (Rubella virus immunoglobulin G (IgG) antibody IVD) 30221 | C | Renewal passed |
| MDIR-0000553 | VIDAS RUB IGM (Rubella virus immunoglobulin M (IgM) antibody IVD) 30214 | C | Renewal passed |
| MDIR-0002503 | VIDAS SARS-COV-2 IgG (9COG) Code:423834 | C | Renewal passed |
| MDIR-0003090 | VIDAS SARS-COV-2 IgG II Kit [424114] [60 Tests] | C | Valid to Dec 2026 |
| MDIR-0002504 | VIDAS SARS-COV-2 IgM (9COM) | C | Renewal passed |
| MDIR-0005547 | VIDAS TB-IGRA 423111 M. tuberculosis (TB) infection detection kit | C | Valid to Sep 2028 |
| MDIR-0002095 | VIDAS TOTAL IgE [30419] | C | Renewal passed |
| MDIR-0001188 | VIDAS TOXO IGG II (Toxoplasmosis IgG) | C | Renewal passed |
| MDIR-0000555 | VIDAS TOXO IGM (Toxoplasma gondii immunoglobulin M (IgM) antibody IVD) 30202 | C | Renewal passed |
| MDIR-0000554 | VIDAS TPSA (Total prostate specific antigen (PSA) IVD) 30428 | C | Renewal passed |
| MDIR-0002097 | VITEK 2 NH [21346 NH] | C | Renewal passed |
| MDIR-0002818 | Xpert BCR ABL Ultra (BCR ABL Assay kit) [GXBCRABL-10] | C | Renewal passed |
| MDIR-0005540 | Xpert C. difficile. BT C. difficile. BT assay | C | Valid to Sep 2028 |
| MDIR-0000514 | Xpert CT/NG (Chlamydia trachomatis / Neisseria gonorrhoeae) Test Kit GXCT/NG-CE-10 GXCT/NG-CE-120 | C | Renewal passed |
| MDIR-0002581 | Xpert FII & FV Xpert Factor II & Factor V Assay [GXFIIFV-10] | C | Renewal passed |
| MDIR-0002820 | Xpert HCV VL Fingerstick Hepatitis C Virus-Viral Load Assay kit [GXHCV-FS-CE-10] | C | Renewal passed |
| MDIR-0001194 | Xpert HPV (HPV Assay) | C | Renewal passed |
| MDIR-0002819 | Xpert MRSA (IVD kit) [GXMRSA-NXG-CE-1 0 GXMRSA-NXG-CE-12 0 GXMRSA/SA-SSTI-C E GXMRSA/SABC-CE-1 0 ] | C | Renewal passed |
| MDIR-0001195 | Xpert MTB/RIF Ultra | C | Renewal passed |
| MDIR-0003939 | Xpert MTB/XDR (RT-PCR Kit) [GXMTB/XDR-10] | C | Valid to Nov 2027 |
| MDIR-0005541 | Xpert Xpress CoV-2/Flu/RSV plus XP3COV2/FLU/RSV-1 0 RT-PCR kit | C | Valid to Sep 2028 |
| MDIR-0002040 | Xpert Xpress Flu/RSV Assay kit Xpert Xpress Flu/RSV Ref No. XPRSFLU/RSV-CE-10 | C | Renewal passed |
| MDIR-0002662 | Xpert Xpress SARS-CoV-2 (Kit) (real time RT PCR kit) [XPRSARS-COV2-10] | C | Renewal passed |
| MDIR-0002667 | API ID Strip Range | B | Renewal passed |
| MDIR-0000199 | Avanti + Sheath Introducers | B | Renewal passed |
| MDIR-0001196 | BRITE Tip Catheter Sheath Introducer | B | Renewal passed |
| MDIR-0002770 | CAPI 3 IMMUNOTYPING Kit | B | Renewal passed |
| MDIR-0002771 | CAPI 3 PROTEIN(E) Kit | B | Renewal passed |
| MDIR-0002772 | CAPI 3 URINE Kit | B | Renewal passed |
| MDIR-0002767 | CAPILLARYS 3 | B | Renewal passed |
| MDIR-0002768 | CAPILLARYS 3-CDT Kit | B | Renewal passed |
| MDIR-0002769 | CAPILLARYS 3-Hb A1c Kit | B | Renewal passed |
| MDIR-0009143 | CAPILLARYS HEMOGLOBIN(E) Kit Hemoglobin separation kit | B | Valid to Apr 2030 |
| MDIR-0009144 | CAPILLARYS Immunotyping Kit Monoclonal protein detection kit | B | Valid to Apr 2030 |
| MDIR-0009142 | CAPILLARYS PROTEIN(E) 6 Kit Protein separation kit | B | Valid to Apr 2030 |
| MDIR-0002880 | Cordis RAIN Sheath Trans radial (Catheter Sheath Introducer) | B | Valid to Oct 2026 |
| MDIR-0003091 | Dynamiker Fungal Infection Detection Kit | B | Valid to Dec 2026 |
| MDIR-0002175 | E-Test | B | Renewal passed |
| MDIR-0000510 | FilmArray Blood Culture Identification (BCID) Panel | B | Renewal passed |
| MDIR-0000507 | FilmArray Gastrointestinal (GI) Panel | B | Renewal passed |
| MDIR-0000511 | FilmArray Respiratory Panel 2 plus (RP2plus) | B | Renewal passed |
| MDIR-0001699 | Hemo Control Haemoglobin Measuring System Ref: 3040-0010-0218 | B | Renewal passed |
| MDIR-0002821 | Leica Bond IHC Reagents & Antibodies (Immunoglobulins) [PA0061, PA0278, PA0905] | B | Renewal passed |
| MDIR-0003092 | MINICAP CDT Kit (Human Serum Transferrin Isoforms Separation Kit) [2208, 2228, 4761] | B | Valid to Dec 2026 |
| MDIR-0003023 | MINICAP HbA1c Kit (HbA1c Analyzing Kit) [2215] | B | Valid to Nov 2026 |
| MDIR-0003086 | MINICAP Hemoglobin Kit | B | Valid to Dec 2026 |
| MDIR-0003022 | MINICAP Immunotyping Kit (Monoclonal proteins Analyzing Kit) [2300] | B | Valid to Nov 2026 |
| MDIR-0003020 | MINICAP Protein (E) Kit (Human Serum Protein Separation Kit) [2203, 2223] | B | Valid to Nov 2026 |
| MDIR-0003021 | Minicap Urine Kit (Urine sample Preparation Kit) [2013] | B | Valid to Nov 2026 |
| MDIR-0009582 | MyoSure Tissue Removal System | B | Valid to Jun 2030 |
| MDIR-0009872 | Panther Fusion Flu A/B/RSV Assay kit (A multiplex real time PCR (RT-PCR kit) [Panther… | B | Valid to Jul 2030 |
| MDIR-0001698 | Que-Lab Analyzer System [HbAIC Measuring System] Model: 0110-0000 | B | Renewal passed |
| MDIR-0003025 | Revital-Ox Resert High Level Disinfectant (Medical Device Disinfectant) [Ref: 4445AWEC] | B | Valid to Nov 2026 |
| MDIR-0001197 | SaMag Viral Nucleic Acid Extraction Kit & System [Viral Nucleic Acid Extraction Kit] | B | Renewal passed |
| MDIR-0003024 | VIDAS BRAHMS PCT (Procalcitonin (PCT) IVD [30450] | B | Valid to Nov 2026 |
| MDIR-0002736 | VIDAS Fertility Panel | B | Renewal passed |
| MDIR-0001822 | VIDAS H. pylori IgG Test Kit [VIDAS H. pylori IgG Ref. 30192 30 Tests] | B | Renewal passed |
| MDIR-0009477 | VIDAS Protein C Plasma Protein C Detection Kit [30115] | B | Valid to May 2030 |
| MDIR-0001823 | VIDAS PTH (1-84) Test Kit [VIDAS PTH (1-84) Ref. 422010 30 Tests] | B | Renewal passed |
| MDIR-0002737 | VIDAS Thyroid Panel | B | Renewal passed |
| MDIR-0002174 | VIDAS Total 05-OH Vitamin D [25-hydroxy Vitamin D IVD] [30463] | B | Renewal passed |
| MDIR-0009478 | VIDAS TSH3 Thyrotropin detection kit [30441] | B | Valid to May 2030 |
| MDIR-0003940 | VITEK 2 AST Cards | B | Valid to Nov 2027 |
| MDIR-0002666 | VITEK 2 ID Cards | B | Renewal passed |
| MDIR-0000515 | VIZUMAX HD (Barium Sulfate) | B | Renewal passed |
| MDIE-0002044 | ABL9 Analyzer System Blood Gas, Electrolyte, and Metabolite Analyzer [393-899, 945-852, 945-853, 945-854, 945-855,… | A | Valid to Jul 2030 |
| MDIE-0002009 | Aptima Assay Fluids Kit | A | Valid to May 2030 |
| MDIE-0002008 | Aptima Auto Detect Kit | A | Valid to May 2030 |
| MDIE-0001254 | Aptima Specimen Transfer kit | A | Valid to May 2030 |
| MDIE-0000334 | Bio Optica Slide Staining Sets [10-10, 10-20, 10-30, 10-33, 10-42] | A | Valid to Nov 2026 |
| MDIE-0001740 | Bio-Optica Disposable Embedding Molds (DISPOMOLDS) Embedding molds | A | Valid to Apr 2030 |
| MDIE-0000442 | Bio-Optica Histology Cassettes | A | Valid to Oct 2027 |
| MDIE-0000440 | Bio-Optica Microscope Slide and Cover glass | A | Valid to Oct 2027 |
| MDIE-0000441 | Bio-Optica Stainless Steel Embedding Mold (Bio-mold) | A | Valid to Oct 2027 |
| MDIE-0000305 | Capillarys 3 OCTA Instrument [1245] | A | Renewal passed |
| MDIE-0000306 | CAPILLARYS 3 TERA Instrument and Accessories [1246, 1248] | A | Renewal passed |
| MDIE-0001792 | Celerity 20 HP Biological Indicator System | A | Valid to Apr 2030 |
| MDIE-0001742 | Color-Gram 2-F Gram Stain | A | Valid to Apr 2030 |
| MDIE-0000332 | Film Array Instrument System [Film Array Torch System [HTFA-ASY-0104] Film Array Torch Module (HTFA-SUB-0103)… | A | Valid to Nov 2026 |
| MDIE-0000315 | GeneRotex96 (Nucleic Acid Extractor) | A | Valid to Oct 2026 |
| MDIE-0000331 | GeneXpert Instrument Systems [GX-I, GX-II, GX-IV, GX-XVI, GX-I R2, GX-II R2, GX-IV R2, GX-XVI… | A | Valid to Nov 2026 |
| MDIE-0000294 | Gentier 96E (Real-Time PCR System) | A | Renewal passed |
| MDIE-0000439 | Hinge Free (Instrument Lubricant) [103105, 103108, 103172PE, 1031T4PE] | A | Valid to Oct 2027 |
| MDIE-0000316 | Hologic Panther System [303095] | A | Valid to Oct 2026 |
| MDIE-0001994 | Leica DM IL LED Microscope | A | Valid to May 2030 |
| MDIE-0001993 | Leica DM1000 Microscope | A | Valid to May 2030 |
| MDIE-0001995 | Leica DMi8 Microscope | A | Valid to May 2030 |
| MDIE-0000335 | Minicap Flex Piercing Instrument & Accessories (Capillary Electrophoresis Instrument) [1232] | A | Valid to Nov 2026 |
| MDIE-0002006 | NextSeq 550Dx instrument (DNA sequencing instrument) | A | Valid to May 2030 |
| MDIE-0002007 | NextSeq 550Dx Reagent kit High Output Reagent Kit (Sample Preparation kit) | A | Valid to May 2030 |
| MDIE-0000438 | PRE-Klenz (Instrument Transport Gel) [150377] | A | Valid to Oct 2027 |
| MDIE-0000333 | Prolystica Cleaning Chemistry (RESTORE Descaler & Neutralizing detergent) [1C45T6WR] | A | Valid to Nov 2026 |
| MDIE-0001785 | Revital-Ox 230cm/2.5mm Channel Brush Kit [100 Kits/case] [2D83QH] | A | Valid to May 2030 |
| MDIE-0000258 | SaCycler-96 Real time PCR System Code: SC-96I | A | Renewal passed |
| MDIE-0002004 | Selenite F-broth (Bacteriology Culture Media Tube) [42099] | A | Valid to May 2030 |
| MDIE-0000449 | VC mini VIDAS | A | Valid to Oct 2027 |
| MDIE-0002003 | VIDAS 3 [412590 | A | Valid to May 2030 |
| MDIE-0001879 | VITEK 2 0.45% Sodium Chloride Diluent Saline Bag | A | Valid to Apr 2030 |
| MDIE-0002005 | Vitek MS instrument [410895] | A | Valid to May 2030 |
| MDIE-0001741 | Vitek MS Prime Mass spectrometry system [423281] | A | Valid to Apr 2030 |
| MDIE-0000448 | VITEK2 Family of instruments (VITEK2 Compact, VITEK2 and VITEK2 XL) | A | Valid to Oct 2027 |
| MDIE-0000443 | Xpert Urine Specimen Collection Kit Code: URINE/A-50 | A | Valid to Oct 2027 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.