Medical device registration holder
Sure Bio Diagnostics & Pharmaceuticals
63 DRAP registrations and enlistments (11 Class A, 15 Class B, 25 Class C, 12 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Sure Bio Diagnostics & Pharmaceuticals
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0006263 | Anti-A (Anti-AB01)/ Anti-B (Anti-AB02)/ Anti D (Anti-Rh1)/ ortho biovue system ABD Confirmation cassettes (100… | D | Valid to Feb 2029 |
| MDIR-0006267 | Anti-A /Anti-B /Anti-A, B/Anti-D/ control /Anti IgG Ortho Biovue system Newborn cassettes (100 Pack)… | D | Valid to Feb 2029 |
| MDIR-0006264 | Anti-A /Anti-B /Anti-A/B/Anti-D/Anti CDE/ control Ortho Biovue system ABO-Rh grouping cassettes (400 Pack) CAT#… | D | Valid to Feb 2029 |
| MDIR-0006266 | Anti-A /Anti-B /Anti-A/B/Anti-D/Anti D control Ortho Biovue system ABO-DD Grouping cassettes (100 Pack) CAT#… | D | Valid to Feb 2029 |
| MDIR-0006270 | Anti-A /Anti-B /Anti-D Ortho Biovue system ABD confirmation cassettes (100 Pack) CAT# 707135 | D | Valid to Feb 2029 |
| MDIR-0006268 | Anti-A /Anti-B /Anti-D/ Control /Reverse Dileunt Ortho Biovue system ABO Rh/Reverse Grouping cassettes (100… | D | Valid to Feb 2029 |
| MDIR-0006265 | Anti-C /Anti-E /Anti-C/B/Anti-E/Anti K/ control Ortho Biovue system Rh/K cassettes (400 Pack) CAT# 707280… | D | Valid to Feb 2029 |
| MDIR-0003795 | Ortho 0.8% Affirmagen Reagent (Reagent Red Blood Cells) [719202] | D | Valid to Oct 2027 |
| MDIR-0003794 | Ortho BioVue System [Anti-Human Globulin Anti-IgG, -C3d; polyspecific] Poly Cassette [707300 (400 cassettes) 707350… | D | Valid to Oct 2027 |
| MDIR-0006269 | Reverse Dileunt Ortho Biovue system Reverse Dileunt cassettes (400 Pack) CAT# 707580 | D | Valid to Feb 2029 |
| MDIR-0006271 | Screening reagents Reagent red blood cell 0.8% Affirmagen (2 x 10 mL) Cat #… | D | Valid to Feb 2029 |
| MDIR-0003796 | Syphilis Ab One version ULTRA ELISA | D | Valid to Oct 2027 |
| MDIR-0003800 | COBE Spectra Dual Needle Extended Life Platelet Set with LRS Chamber (Platelet collection Needle) | C | Valid to Oct 2027 |
| MDIR-0006256 | Cross match Anti IgG, - C3d/polyspecific/Neutr al Ortho Biovue Cat # 707355 Pack size… | C | Valid to Feb 2029 |
| MDIR-0006257 | Cross match Anti IgG, - C3d/polyspecificOrtho Biovue Cat # 707350 Pack size 100 Anti… | C | Valid to Feb 2029 |
| MDIR-0006254 | Cross match Anti IgG, -Anti C3b, C3d/Control Ortho Biovue system Cat # 707165 | C | Valid to Feb 2029 |
| MDIR-0006255 | Cross match Anti IgG, Ortho Biovue system Cat # 707450 | C | Valid to Feb 2029 |
| MDIR-0009338 | EDiagnosis Blood Gas Testing Cartridge | C | Valid to May 2030 |
| MDIR-0009341 | EDiagnosis Creatine Kinase Isoenzyme (CK-MB) Test Kit (Immunofluorescence Method) | C | Valid to May 2030 |
| MDIR-0009339 | EDiagnosis High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence Method) | C | Valid to May 2030 |
| MDIR-0009342 | EDiagnosis Interleukin 6 (IL-6) Test Kit | C | Valid to May 2030 |
| MDIR-0009340 | EDiagnosis N-terminal pro brain Natriuretic Peptide (NT-proBNP) Test Kit | C | Valid to May 2030 |
| MDIR-0006258 | Red blood Cell identification reagents 0.8% RESOLVE Panel A (1 x 3 mL) Cat#… | C | Valid to Feb 2029 |
| MDIR-0006262 | Red blood Cell identification reagents 0.8% Selectogen 3 x 10 mL) Cat# 719602 Selectogen… | C | Valid to Feb 2029 |
| MDIR-0006259 | Red blood Cell identification reagents 0.8% SurgiScreen INT (3 x 10 mL) CAT# 719102… | C | Valid to Feb 2029 |
| MDIR-0006261 | Red blood Cell identification reagents ORTHO Coombs Control Cat # 6901868 | C | Valid to Feb 2029 |
| MDIR-0006260 | Red blood Cell identification reagents RESOLVE Panel A (1 x 3 mL) Cat #… | C | Valid to Feb 2029 |
| MDIR-0003803 | Spectra Optia BMP Accessory set [11300] | C | Valid to Oct 2027 |
| MDIR-0003802 | Spectra Optia Collection Set [10120] | C | Valid to Oct 2027 |
| MDIR-0003797 | Spectra Optia Collection Set [12120] | C | Valid to Oct 2027 |
| MDIR-0003806 | Spectra Optia IDL Set [12320, 10310] | C | Valid to Oct 2027 |
| MDIR-0003804 | Spectra Optia Platelet, Plasma Set [10400] | C | Valid to Oct 2027 |
| MDIR-0003807 | Terumo BCT Inc. Anticoagulant Citrate Dextrose Solution [750ml Cat# 40800] | C | Valid to Oct 2027 |
| MDIR-0005214 | Terumo BCT Inc. Anticoagulant Citrate Dextrose Solution [750ml Cat# 40818] | C | Valid to Jun 2028 |
| MDIR-0009332 | V-CHEK C-reactive Protein (hsCRP&CRP) Rapid Test Kit [5084C4X025, 5084C4X050] | C | Valid to May 2030 |
| MDIR-0009335 | V-CHEK Cardiac Troponin I (cTnI) Rapid Test Kit [5184C4X025, 5184C4X050] | C | Valid to May 2030 |
| MDIR-0009333 | V-CHEK D Dimer (DD) Rapid Test Kit [5274C4X025, 5274C4X050] | C | Valid to May 2030 |
| MDIR-0003129 | AccuDiag Chikungunya IgG/ IgM Elisa Cluster [8112-25, 8113-25] | B | Valid to Jan 2027 |
| MDIR-0002508 | Amphetamine Urine RapidDip, Barbiturate Urine RapiDip Insta Test, Benzodiazepine Urine RapiDip InstaTest, Methamphetamine Urine… | B | Renewal passed |
| MDIR-0009573 | EDiagnosis Hemoglobin A1c (HbA1c) Test Kit | B | Valid to Jun 2030 |
| MDIR-0009343 | EDiagnosis Vitamin D Test Kit | B | Valid to May 2030 |
| MDIR-0006872 | ImmunoCard Mycoplasma Cat No.709030 ImmunoCard STAT HpSA Cat No.750220 ImmunoCard Stat C.Diff GDH &… | B | Valid to Apr 2029 |
| MDIR-0006871 | Immunocard STAT Rota Adeno Noro 2 Cat No. 750320 TRU RSV Cat No. 751330… | B | Valid to Apr 2029 |
| MDIR-0006822 | Nunc IVF Center Well Dish | B | Valid to Apr 2029 |
| MDIR-0006870 | Nunc IVF Center Well Dish Cat # 150260 Nunc IVF ICSI Dish Cat #… | B | Valid to Apr 2029 |
| MDIR-0003799 | Reveos Automated Blood Processing System [Automated Blood Processing System] | B | Valid to Oct 2027 |
| MDIR-0003801 | Spectra Optia Apheresis System | B | Valid to Oct 2027 |
| MDIR-0003798 | Spectra Optia Exchange Set | B | Valid to Oct 2027 |
| MDIR-0003805 | Spectra Optia Exchange Set [10220] | B | Valid to Oct 2027 |
| MDIR-0009334 | V-CHEK Hemoglobin A1c (HbA1c) Rapid Test Kit [5257C4X025, 5257C4X050] | B | Valid to May 2030 |
| MDIR-0009336 | V-CHEK Thyroid Hormones (Cluster) Triiodothyronine (T3) Thyroxine (T4) Free T3 (FT3) Free T4 (FT4)… | B | Valid to May 2030 |
| MDIR-0009337 | V-CHEK Vitamin D Rapid Test Kit [5314C4X025, 5314C4X050] | B | Valid to May 2030 |
| MDIE-0000990 | Blood Gas Analyzer [PT1000] | A | Valid to Feb 2030 |
| MDIE-0000782 | Cat No. 6904629 BioVue Manual Workstation Cat No. 6842223 ORTHO Optix Reader BioVue Cat… | A | Valid to Feb 2029 |
| MDIE-0000991 | Fluorescence Immunity Analyzer [Model: QFT9000] | A | Valid to Feb 2030 |
| MDIE-0001443 | M/s.Nalge Nunc International Corporation 75 Panorama Creek Drive, Rochester, New York, USA, 14625 | A | Valid to Mar 2030 |
| MDIE-0000781 | Ortho Vision Analyzer BV (6904579) Ortho Vision Max Analyzer BV ( 6904578) Antibody Enhancment… | A | Valid to Feb 2029 |
| MDIE-0001989 | RED CELL Gel Card Centrifuge [8682484709260] | A | Valid to May 2030 |
| MDIE-0001990 | RED CELL Gel Card Incubator [8682484709277] | A | Valid to May 2030 |
| MDIE-0001991 | RED CELL Gel Card Reader [8682484709284] | A | Valid to May 2030 |
| MDIE-0001992 | RED CELL LISS 500ml [8682484709017] | A | Valid to May 2030 |
| MDIE-0001970 | V-CHEK Immunofluorescence Analyzer [DC903A] | A | Valid to May 2030 |
| MDIE-0001971 | V-CHEK Incubator [DC914A] | A | Valid to May 2030 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.