Medical device registration holder
Labserv
56 DRAP registrations and enlistments (10 Class A, 46 Class B) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Labserv
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0009736 | Anti-Acetylcholine Receptor ELISA (IgG) [EA 1435-9601 G] | B | Valid to Jul 2030 |
| MDIR-0007568 | Anti-Aquaporin-4 IIFT Immuno-chemistry Test Kit [FA 1128-1005-50] | B | Valid to Dec 2029 |
| MDIR-0009737 | Anti-CCP ELISA (IgG) [EA 1505-9601 G] | B | Valid to Jul 2030 |
| MDIR-0009731 | Anti-dsDNA-NcX ELISA (IgG) [EA 1572-9601 G | B | Valid to Jul 2030 |
| MDIR-0009733 | Anti-Gliadin (GAF-3X) ELISA (IgG) [EV 3011-9601 G] | B | Valid to Jul 2030 |
| MDIR-0007570 | Anti-MyelinOligidendro cyte Glycoprotein (MOG) IIFT Immuno-chemistry Test Kit [FA 1156-1005-50] | B | Valid to Dec 2029 |
| MDIR-0009732 | Anti-Myeloperoxidase ELISA (IgG) [EA 1211-9601 G] | B | Valid to Jul 2030 |
| MDIR-0007572 | Anti-Phopholipase A2 Receptor (PLA2R) IIFT Immuno-chemistry Test Kit [FA 1254-1005-50] | B | Valid to Dec 2029 |
| MDIR-0009734 | Anti-PLA2R ELISA (IgG) [EA 1254-9601 G | B | Valid to Jul 2030 |
| MDIR-0009735 | Anti-PR3-hn-hr ELISA (IgG) [EA 1201-9601-2 G | B | Valid to Jul 2030 |
| MDIR-0009730 | Anti-SLA/LP ELISA (IgG) [EA 1302-9601 G | B | Valid to Jul 2030 |
| MDIR-0009729 | Anti-Tissue Transglutaminase ELISA (IgA) [EA 1910-9601 A] | B | Valid to Jul 2030 |
| MDIR-0009728 | Anti-Tissue Transglutaminase ELISA (IgG) [EA 1910-9601 G] | B | Valid to Jul 2030 |
| MDIR-0004837 | Euroline Ana Profile 23 ( IgG) Ana Profile 23 (IgG) [DL 1590-1601-23G] | B | Valid to Feb 2028 |
| MDIR-0004838 | Euroline Ana Profile et Mi-2 et Ku (IgG) Ana Profile et Mi-2 et Ku… | B | Valid to Feb 2028 |
| MDIR-0004832 | Euroline Anti- MPO, PR3 and GBM (IgM) Anti-MPO, PR3 and GBM (IgG) [DL 1200-1601-3… | B | Valid to Feb 2028 |
| MDIR-0004831 | Euroline AntiGangliosides Profile 2 (IgG) Anti-Gangliosides Profile 2 (IgG) [DL 1130-1601-2 G] | B | Valid to Feb 2028 |
| MDIR-0004835 | Euroline Autoimmnune Inflammatory Myopathies 16 Ag (IgG) Autoimmune Inflammatory Myopathies 16 AG (IgG) [DL… | B | Valid to Feb 2028 |
| MDIR-0004833 | Euroline Autoimmune Liver Disease (IgG) Autoimmune Liver Disease-IgG [DL 1300-1601-4 G ] | B | Valid to Feb 2028 |
| MDIR-0004834 | Euroline Myositis Profile 3 (IgG) Myositis Profile 3 (IgG) [DL 1530-1601-3 G ] | B | Valid to Feb 2028 |
| MDIR-0004829 | Euroline Neruroline Antigens Profile 2 (IgG) Neuronal Antigens Profile 2 (IgG) [DL 1111-1601-2 G] | B | Valid to Feb 2028 |
| MDIR-0004830 | Euroline Neuronal Antigens Profile Plus RST (IgG) Neuronal Antigens Profile Plus RST (IgG) [DL… | B | Valid to Feb 2028 |
| MDIR-0004836 | Euroline Systemic Sclerosis [Nucleoli] Profile [IgG] Systemic Sclerosis [Nucleoli] Profile [IgG] [DL 1532-1601 G] | B | Valid to Feb 2028 |
| MDIR-0007573 | EUROPLUS Granulocyte Mosaic 25 Immuno-chemistry Test Kit [FA 1201- 1005-25] | B | Valid to Dec 2029 |
| MDIR-0009634 | Human IgG 4 (M-89) Subclass Liquid Reagent Kit | B | Valid to Jul 2030 |
| MDIR-0007569 | IIFT: Autoimmune Encephalitis Mosaic 1 Immuno-chemistry Test Kit [FA 112d- 1005-1] | B | Valid to Dec 2029 |
| MDIR-0007567 | IIFT: Autoimmune Encephalitis Mosaic 6 Immuno-chemistry Test Kit [FA 112d- 1005-6] | B | Valid to Dec 2029 |
| MDIR-0007574 | IIFT: CIBD Profile 3 Immuno-chemistry Test Kit [FA 1391- 1005-4] | B | Valid to Dec 2029 |
| MDIR-0007571 | IIFT: Crithidia luciliac sensitive (anti-dsDNA) Immuno-chemistry Test Kit [FA 1572-1010-1] | B | Valid to Dec 2029 |
| MDIR-0007576 | IIFT: Diabetes mellitus screen Immuno-chemistry Test Kit [FA 1020-1005-3] | B | Valid to Dec 2029 |
| MDIR-0007575 | IIFT: HEp-2 Immuno-chemistry Test Kit [FA 1520- 1005, FA 1520-1010] | B | Valid to Dec 2029 |
| MDIR-0009644 | Optilite Anti-Streptolysin O Kit | B | Valid to Jul 2030 |
| MDIR-0009643 | Optilite Beta-2 Microglobulin Kit | B | Valid to Jul 2030 |
| MDIR-0009642 | Optilite C-Reactive (M-89) Protein Reagent | B | Valid to Jul 2030 |
| MDIR-0009631 | Optilite C1 Inactivator Kit | B | Valid to Jul 2030 |
| MDIR-0009640 | Optilite C3c Kit | B | Valid to Jul 2030 |
| MDIR-0009641 | Optilite C4 Kit | B | Valid to Jul 2030 |
| MDIR-0009636 | Optilite IgA Kit | B | Valid to Jul 2030 |
| MDIR-0009630 | Optilite IgG 4 Kit | B | Valid to Jul 2030 |
| MDIR-0009635 | Optilite IgG Kit | B | Valid to Jul 2030 |
| MDIR-0009637 | Optilite IgG1 Kit | B | Valid to Jul 2030 |
| MDIR-0009638 | Optilite IgG2 Kit | B | Valid to Jul 2030 |
| MDIR-0009639 | Optilite IgG3 Kit | B | Valid to Jul 2030 |
| MDIR-0009633 | Optilite IgM Kit | B | Valid to Jul 2030 |
| MDIR-0009629 | Optilite Rheumatoid Factor Kit | B | Valid to Jul 2030 |
| MDIR-0009632 | VaccZymeTM Anti-PCP IgG | B | Valid to Jul 2030 |
| MDIE-0002025 | Flexmap 3D Calibration Kit Calibration Kit for Multiplex Test Systems | A | Valid to May 2030 |
| MDIE-0000992 | Flexmap 3D Instrument Multiplex Test Systems | A | Valid to Feb 2030 |
| MDIE-0002026 | Flexmap 3D Performance Verification Kit Reagent for Multiplex Test Systems | A | Valid to May 2030 |
| MDIE-0000994 | Luminex 100/200 Calibraion Kit Reagent for Multiplex Test Systems | A | Valid to Feb 2030 |
| MDIE-0000993 | Luminex 100/200 performance Verification Kit Reagent for Multiplex Test Systems | A | Valid to Feb 2030 |
| MDIE-0002027 | Luminex 200TM System with xPONENT | A | Valid to May 2030 |
| MDIE-0000981 | Optilite Analyzer | A | Valid to Feb 2030 |
| MDIE-0000983 | Optilite Diluent | A | Valid to Feb 2030 |
| MDIE-0000982 | Optilite Special Wash 1 | A | Valid to Feb 2030 |
| MDIE-0000995 | xMAP Sheath Fluid PLUS Reagent for Multiplex Text System | A | Valid to Feb 2030 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.