Medical device registration holder
MOODY Global Services
83 DRAP registrations and enlistments (8 Class A, 3 Class B, 52 Class C, 20 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of MOODY Global Services
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0005939 | DAAN GENE (2019-nCoV Delta Variant Detection Kit (PCR-Fluorescence Probing) | D | Valid to Dec 2028 |
| MDIR-0005940 | DAAN GENE (Detection Kit for 2019-nCov (N/E/RDRP Gene) | D | Valid to Dec 2028 |
| MDIR-0005938 | DAAN GENE (Detection kit for 2019-nCov (PCR-Fluorescence) [[DA 0990] | D | Valid to Dec 2028 |
| MDIR-0005937 | DAAN GENE (Detection kit for 2019-nCov (PCR-Fluorescence) [DA1070] | D | Valid to Dec 2028 |
| MDIR-0005934 | DAAN GENE (Detection kit for 2019-Novel Coronavirus (2019-nCov) RNA (PCR-Fluorescenc Probing) | D | Valid to Dec 2028 |
| MDIR-0005941 | DAAN GENE (Detection Kit for influenza AB and 2019-nCoV (PCR-Fluorescence Probing) | D | Valid to Dec 2028 |
| MDIR-0005936 | DAAN GENE (Detection kit for SARS-Cov-2 UK and South African Variants (PCR-Fluorescence) | D | Valid to Dec 2028 |
| MDIR-0005935 | DAAN GENE (Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR_Fluorescence Probing) | D | Valid to Dec 2028 |
| MDIR-0005933 | DAAN GENE (Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR-Fluorescence Probing) | D | Valid to Dec 2028 |
| MDIR-0005482 | Lifotronic SARS CoV-2 IgG (e CLIA) | D | Valid to Aug 2028 |
| MDIR-0005480 | Lifotronic SARS CoV-2 IgG Assay Kits (Lateral Flow Immunoassay) | D | Valid to Aug 2028 |
| MDIR-0005481 | Lifotronic SARS CoV-2 IgM (e CLIA) | D | Valid to Aug 2028 |
| MDIR-0005479 | Lifotronic SARS CoV-2 Neutralization Ab (e CLIA) | D | Valid to Aug 2028 |
| MDIR-0005483 | Lifotronic SARS CoV-2 Neutralization Ab (Lateral Flow Immunoassay) | D | Valid to Aug 2028 |
| MDIR-0006481 | Realy (Influenza A&B Rapid Test Device) | D | Valid to Mar 2029 |
| MDIR-0006480 | Realy (Malaria p.f/p.v Rapid Test Device) | D | Valid to Mar 2029 |
| MDIR-0006475 | Realy (Malaria p.f/pan Antigen Rapid Test Device) | D | Valid to Mar 2029 |
| MDIR-0006473 | Realy (SARS-Cov-2 & Influenza A&B Combo Rapid Test Cassette (swab) | D | Valid to Mar 2029 |
| MDIR-0006471 | Safecath (Disposable Central Venous Catheter Kit) | D | Valid to Mar 2029 |
| MDIR-0006470 | Target Medical (Disposable Hemodialysis Catheter Kit) | D | Valid to Mar 2029 |
| MDIR-0006487 | Lifotronic (CK MB (Electro chemiluminescence Immunoassay) | C | Valid to Mar 2029 |
| MDIR-0006488 | Lifotronic (Heart Fatty Acid-Binding Protein (H-FABP) Assay kits (Lateral Flow Immunoassay) | C | Valid to Mar 2029 |
| MDIR-0006489 | Lifotronic (N terminal pro B type Natriuretic Peptide STAT(NT-proBNP STAT) (Electrochemiluminesc ence Immunoassay) | C | Valid to Mar 2029 |
| MDIR-0005346 | Lifotronic Alpha Fetoprotein (Electrochemiluminesc ence Immunoassay) (eCLIA) [Size: 50T, 2x50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005343 | Lifotronic B-Thalassaemia & HBA1c Assay Column (HPLC) [Size: 1 piece/box] | C | Valid to Aug 2028 |
| MDIR-0005344 | Lifotronic B-Thalassaemia & HBA1c Calibrator | C | Valid to Aug 2028 |
| MDIR-0005345 | Lifotronic B-Thalassaemia & HBA1c Control Material [Size: the kit includes control level 1, level… | C | Valid to Aug 2028 |
| MDIR-0005349 | Lifotronic Cancer Antigen 125 (e CLIA) [Size: 50T, 2x50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005347 | Lifotronic Cancer Antigen 15-3 (e CLIA) [Size: 50T, 2x50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005348 | Lifotronic Cancer Antigen 72-4 (e CLIA) [Size: 50T, 2x50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005350 | Lifotronic Carbohydrate Antigen 19-9 (e CLIA) [Size: 50T, 2x50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005351 | Lifotronic Carcinoembryonic Antigen (e CLIA) [Size: 50T, 2x50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005470 | Lifotronic Cardiac Troponin (cTnI) Assay Kits (Lateral flow immunoassay) | C | Valid to Aug 2028 |
| MDIR-0005339 | Lifotronic Chromatographic Column (HPLC) [Size: The kit includes calibrator level 1, level 2. (2x0.1mL;… | C | Valid to Aug 2028 |
| MDIR-0005354 | Lifotronic Creatine Kinase MB (e CLIA) [Size: 1x100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005353 | Lifotronic Creatine Kinase MB STAT (CK-MB STAT) e CLIA [Size: 50T, 2x50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005471 | Lifotronic Cytokeratin Fragments 19 (eCLIA) | C | Valid to Aug 2028 |
| MDIR-0005472 | Lifotronic D-dimer Assay Kits (Lateral flow immunoassay) | C | Valid to Aug 2028 |
| MDIR-0005352 | Lifotronic HbA1c Assay Kit (Lateral flow Immunoassay) | C | Valid to Aug 2028 |
| MDIR-0005340 | Lifotronic HBA1c Calibrator [Size: 1 set (2*0.1mL)] | C | Valid to Aug 2028 |
| MDIR-0005342 | Lifotronic HBA1c Control Material [Size: 1 set (2*0.1mL)] | C | Valid to Aug 2028 |
| MDIR-0005341 | Lifotronic HbA1c Reagent Kit (HPLC) [Size: 200T/box 400T/box] | C | Valid to Aug 2028 |
| MDIR-0005473 | Lifotronic Heart Type Fatty Acid Binding Protein (Electrochemiluminesc ence Immunoassay) | C | Valid to Aug 2028 |
| MDIR-0005469 | Lifotronic High-Sensitivity C Reactive Protein (e CLIA) | C | Valid to Aug 2028 |
| MDIR-0005338 | Lifotronic Lipoprotein Phospholipase A2 [50T, 100T, 2x100T] | C | Valid to Aug 2028 |
| MDIR-0005337 | Lifotronic Multi Control Cardiac Marker | C | Valid to Aug 2028 |
| MDIR-0005474 | Lifotronic Myoglobin (e CLIA) | C | Valid to Aug 2028 |
| MDIR-0005475 | Lifotronic Myoglobin Assay kits (Lateral flow immunoassay) | C | Valid to Aug 2028 |
| MDIR-0005476 | Lifotronic Myoglobin STAT (MYO STAT) e CLIA | C | Valid to Aug 2028 |
| MDIR-0005477 | Lifotronic N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kits (Lateral Flow Immunoassay) | C | Valid to Aug 2028 |
| MDIR-0005478 | Lifotronic Pro-Gastrin Releasing Peptide (Electrochemiluminesc ence Immunoassay) | C | Valid to Aug 2028 |
| MDIR-0005484 | Lifotronic Squamous Cell Carcinoma (e CLIA) | C | Valid to Aug 2028 |
| MDIR-0005485 | Lifotronic Troponin I (e CLIA) | C | Valid to Aug 2028 |
| MDIR-0007226 | Maccura Cancer Antigen CA (CLIA) 125 Reagent Kit | C | Valid to Sep 2029 |
| MDIR-0007227 | Maccura CYFRA21-1 (CLIA) chemiluniscent immunoassay Reagent Kit | C | Valid to Sep 2029 |
| MDIR-0007228 | NIGALE Plasma separator [DIGI PLA 80] | C | Valid to Sep 2029 |
| MDIR-0006468 | OCI (Hollow Fiber Dialyzer) | C | Valid to Mar 2029 |
| MDIR-0006469 | OCI (Hollow Fiber Membrance Hemodialyzer) | C | Valid to Mar 2029 |
| MDIR-0006464 | Purifer (High Flux-Polyethersulfone Hollow Fiber Hemodialyzer) | C | Valid to Mar 2029 |
| MDIR-0006466 | Purifier (Low Flux Polyethersulfone Hollow Fiber hemodialyzer) | C | Valid to Mar 2029 |
| MDIR-0006477 | Realy (Dengue IgG/IgM and NSI Rapid Test Device) | C | Valid to Mar 2029 |
| MDIR-0006472 | Realy (Dengue IgG/IgM Rapid Test Device) [K050216D] | C | Valid to Mar 2029 |
| MDIR-0006478 | Realy (Dengue NS1 Rapid Test Device) | C | Valid to Mar 2029 |
| MDIR-0006279 | Realy (Herpes simplex Virus-I IgG (HSV)-I IgG) Assay Reagent Kit (CMIA) [C2KL001] | C | Valid to Feb 2029 |
| MDIR-0006280 | Realy (Herpes simplex Virus-I/II IgM (HSV)-I IIgM) Assay Reagent Kit (CMIA) [C2KL010] | C | Valid to Feb 2029 |
| MDIR-0006281 | Realy (Herpes simplex Virus-II IgG (HSV)-II IgG) Assay Reagent Kit (CMIA) [C2KL002] | C | Valid to Feb 2029 |
| MDIR-0006479 | Realy (Syphilis Rapid Test Device) | C | Valid to Mar 2029 |
| MDIR-0006482 | Realy (Syphilis Rapid Test Device) | C | Valid to Mar 2029 |
| MDIR-0006476 | Realy (Tuberculosis Rapid Test Device) | C | Valid to Mar 2029 |
| MDIR-0006484 | Realy (Typhoid IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) | C | Valid to Mar 2029 |
| MDIR-0006483 | Realy (Typhoid IgG/IgM Rapid Test Device) | C | Valid to Mar 2029 |
| MDIR-0006474 | Realy HEV IgM Rapid Test Device (Serum/Plasma) | C | Valid to Mar 2029 |
| MDIR-0005486 | Lifotronic Testosterone(e CLIA) | B | Valid to Aug 2028 |
| MDIR-0006465 | OCI (Arteriovenous Fistula Needle Sets) | B | Valid to Mar 2029 |
| MDIR-0006467 | OCI (Hemodialysis Blood Tubing Sets) | B | Valid to Mar 2029 |
| MDIE-0000760 | DAAN GENE Nucleic Acid Extraction Instrument | A | Valid to Dec 2028 |
| MDIE-0000763 | DAAN GENE Nucleic acid extraction kit | A | Valid to Dec 2028 |
| MDIE-0000762 | DAAN GENE Nucleic acid isolation or purification Reagent | A | Valid to Dec 2028 |
| MDIE-0000759 | DAAN GENE RNA/DNA PURIFICATION KIT (SPIN COLUMN) | A | Valid to Dec 2028 |
| MDIE-0000761 | DAAN GENE Specimen Preservation Reagent | A | Valid to Dec 2028 |
| MDIE-0001595 | Lifotronic Buffer | A | Valid to Apr 2030 |
| MDIE-0001596 | Lifotronic H8 Hemoglobin Analyzer | A | Valid to Apr 2030 |
| MDIE-0000728 | Lifotronic HBA1c Reagent kit (IEC) | A | Valid to Aug 2028 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.