Medical device registration holder
Med Lab Services
30 DRAP registrations and enlistments (16 Class B, 11 Class C, 3 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Med Lab Services
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0000434 | GeneProof Hepatitis B Virus (HBV) PCR Kit | D | Renewal passed |
| MDIR-0000433 | GeneProof Hepatitis C Virus (HCV) PCR Kit | D | Renewal passed |
| MDIR-0003354 | GeneProof Hepatitis-C Virus (HCV) Diagnostic PCR Kit [HCVD/ISEX/025 HCVD/ISEX/050 HCVD/ISEX/100] | D | Valid to Apr 2027 |
| MDIR-0007436 | GeneProof Cytomegalovirus | C | Valid to Nov 2029 |
| MDIR-0006676 | GeneProof Mycobacterium tuberculosis PCR Kit | C | Valid to Apr 2029 |
| MDIR-0006675 | GeneProof SARS-CoV-2 Advanced PCR Kit | C | Valid to Apr 2029 |
| MDIR-0006674 | GeneProof SARS-CoV-2 Screening PCR Kit | C | Valid to Apr 2029 |
| MDIR-0009687 | Vircell Herpes Simplex 1+2 Elisa IgG/IgM [G/M 1016 | C | Valid to Jul 2030 |
| MDIR-0009868 | Zytolght Glioma 1p/19q probe set [Catalogue no 2272-20] | C | Valid to Jul 2030 |
| MDIR-0009864 | Zytolght Spec ALK dual color break apart probe [Catalogue no 2124-200, 2124-50] | C | Valid to Jul 2030 |
| MDIR-0009867 | Zytolght Spec ERBB2/CEN 17 dual color probe [Catalogue no 2015-200, 2015-50] | C | Valid to Jul 2030 |
| MDIR-0009865 | Zytolght Spec KMT2A dual color break apart probe [Catalogue no 2193-200, 2193-50] | C | Valid to Jul 2030 |
| MDIR-0009863 | Zytolght Spec MDM2/CEN 12 Dual color probe [Catalogue No 2013-200, 2013-50] | C | Valid to Jul 2030 |
| MDIR-0009866 | Zytolght Spec MYC dual color break apart probe [Catalogue no 2090-200, 2090-50] | C | Valid to Jul 2030 |
| MDIR-0006684 | Clinical chemistry electrolytes reagents | B | Valid to Apr 2029 |
| MDIR-0006682 | Clinical chemistry enzymes reagents | B | Valid to Apr 2029 |
| MDIR-0006681 | Clinical chemistry lipid reagents | B | Valid to Apr 2029 |
| MDIR-0006683 | Clinical chemistry substrate reagents | B | Valid to Apr 2029 |
| MDIR-0005529 | Cluster: Diabetes assays (hormones) cluster | B | Valid to Sep 2028 |
| MDIR-0005531 | Cluster: Thyroid profile cluster | B | Valid to Sep 2028 |
| MDIR-0005530 | Fertility Hormone cluster | B | Valid to Sep 2028 |
| MDIR-0005532 | IRMA CA125 antigen | B | Valid to Sep 2028 |
| MDIR-0009681 | Vircell Brucella Elisa IgG [G 1003] | B | Valid to Jul 2030 |
| MDIR-0009682 | Vircell Brucella Elisa IgM [M 1006] | B | Valid to Jul 2030 |
| MDIR-0009684 | Vircell Epstein-Barr VCA Elisa IgG [G 1005 | B | Valid to Jul 2030 |
| MDIR-0009685 | Vircell Epstein-Barr VCA Elisa IgM [M 1005] | B | Valid to Jul 2030 |
| MDIR-0009683 | Vircell Helicobacter Pylori Elisa IgA [A 1022] | B | Valid to Jul 2030 |
| MDIR-0009679 | Vircell Helicobacter Pylori Elisa IgG [G 1022] | B | Valid to Jul 2030 |
| MDIR-0009680 | Vircell Hydatidosis ELISA IgG [G 1006 | B | Valid to Jul 2030 |
| MDIR-0009686 | Vircell Leptospira Elisa IgM [M 1003 | B | Valid to Jul 2030 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.