Medical device registration holder
Lab Diagnostic Systems (SMC) Pvt. Ltd
78 DRAP registrations and enlistments (5 Class A, 19 Class B, 33 Class C, 21 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Lab Diagnostic Systems (SMC) Pvt. Ltd
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0007187 | DOSI-FUSER Slow Flow with Capillary Element | D | Valid to Aug 2029 |
| MDMR-000417 | Glow Aspergillus IgG Ab Fluorescence Immunoassay [Sizes: 40 pcs / pack] | D | Valid to Jan 2030 |
| MDMR-000416 | Glow Candida Ag Fluorescence Immunoassay Candida Ag Lateral Flow Assay [40 pcs / pack] | D | Valid to Jan 2030 |
| MDMR-000418 | Glow Fungus (1-3)-B-D-Glucan Fluorescence Immunoassay Fungus (l-3)-B-D Assay [Sizes: 40 pcs / pack] | D | Valid to Jan 2030 |
| MDMR-000266 | R-test Cryptocccus Capsular Polysaccharide Rapid Test (Cryptococcus neoformans capsular polysaccharide detection kit) R-39050 | D | Valid to Aug 2028 |
| MDMR-000265 | R-test Flu A/B & RSV Rapid Test (Flu RSV detection kit) R-27025 | D | Valid to Aug 2028 |
| MDMR-000262 | R-test HAV IgM/IgG Rapid Test (HAV IgM/IgG detection kit) R-28050 | D | Valid to Aug 2028 |
| MDMR-000184 | R-Test HBsAg Rapid Test Kit. (Hepatitis B Virus Surface Antigen (HBsAg) detection kit) | D | Valid to Jun 2027 |
| MDMR-000333 | R-test HBsAg Self Test Hepatitis B virus surface antigen (HBsAg) self detection kit [1… | D | Valid to May 2029 |
| MDMR-000185 | R-Test HCV Ab Rapid Test Kit. (Hepatitis C detection kit-Coloidal Gold) | D | Valid to Jun 2027 |
| MDMR-000332 | R-test HCV Ab Self Test Hepatitis C self detection kit (Colloidal Gold) [1 test… | D | Valid to May 2029 |
| MDMR-000261 | R-Test HCV/HBsAg/HIV Combo Rapid Test (HAV IgM/IgG detection kit) R-28050 | D | Valid to Aug 2028 |
| MDMR-000285 | R-test HCV/HBsAg/HIV/Syph illis Combo Rapid Test (HCV/HBsAg/HIV/Syp hilis detection kit | D | Valid to Oct 2028 |
| MDMR-000264 | R-test HEV IgM Rapid Test (HEV IgM detection kit) R-29050 | D | Valid to Aug 2028 |
| MDMR-000193 | R-Test HIV 1/2 Ab Rapid Test [R-14050, 50 Tests] | D | Valid to Sep 2027 |
| MDMR-000267 | R-test Leishmania IgM/IgG Rapid Test (Cryptococcus neoformans capsular polysaccharide detection kit) R-36050 | D | Valid to Aug 2028 |
| MDMR-000288 | R-test PSA Rapid Test (PSA detection kit) | D | Valid to Oct 2028 |
| MDMR-000263 | R-test Rotavirus/Adeno Ag Rapid Test (Rotavirus/Adeno antigen detection kit) R-35050 | D | Valid to Aug 2028 |
| MDMR-000289 | R-test TORCH Panel Rapid Test (Rapid qualitative lateral flow test designed for the qualitative… | D | Valid to Oct 2028 |
| MDMR-000290 | R-test Toxo IgG/IgM Rapid Toxo detection kit (Lateral flow chromatographic immunoassay for the simultaneous… | D | Valid to Oct 2028 |
| MDMR-000291 | ViGen Q HCV PCR kit (HCV Quantitative detection) | D | Valid to Oct 2028 |
| MDMR-000517 | * GLOW CK-MB Fluorescence Immunochromatograp hy Kit [40 pcs / pack] | C | Valid to May 2030 |
| MDMR-000523 | * GLOW cTnI/Myo/CK-MB Fluorescence Immunochromatograp hy Kit | C | Valid to May 2030 |
| MDMR-000522 | * GLOW D-Dimer Fluorescence Immunochromatograp hy Kit | C | Valid to May 2030 |
| MDMR-000520 | * GLOW Myoglobin Fluorescence Immunochromatograp hy [40 pcs / pack] | C | Valid to May 2030 |
| MDMR-000519 | * GLOW NT-proBNP Fluorescence Immunochromatograp hy Kit [40 pcs / pack] | C | Valid to May 2030 |
| MDMR-000527 | * GLOW PCT Fluorescence Immunochromatograp hy Kit GLOW PCT Fluorescence Immunochromatograp hy Kit [40… | C | Valid to May 2030 |
| MDMR-000518 | * GLOW Troponin I Fluorescence Immunochromatograp hy Kit [40 pcs / pack] | C | Valid to May 2030 |
| MDIR-0007175 | Double Blood Bag | C | Valid to Aug 2029 |
| MDMR-000350 | GLOW Aspergillus Galactomannan Ag Lateral Flow Assay Aspergillus galactomannan Antigen detection | C | Valid to Aug 2029 |
| MDMR-000206 | i-Sugar Blood Glucose Monitoring System | C | Valid to Nov 2027 |
| MDMR-000165 | R test Covid-19 Rapid Antigen Self Test R-10001 | C | Valid to Feb 2027 |
| MDMR-000164 | R test SARS-CoV-2 Ag R-10050 | C | Valid to Feb 2027 |
| MDMR-000204 | R-test Cholera Ag Rapid Test | C | Valid to Nov 2027 |
| MDMR-000452 | R-test Dengue IgG/IgM & Chikungunya IgG/IgM Combo Rapid Test Dengue IgG/IgM & Chikungunya IgG/IgM… | C | Valid to Jan 2030 |
| MDMR-000194 | R-Test Dengue NS1 Ag & IgM/IgG ab Combo Rapid Test [R-15050, 50 Tests] | C | Valid to Sep 2027 |
| MDMR-000203 | R-test Dengue NS1 Ag & Malaria Pf/Pv Ag Combo Rapid Test | C | Valid to Nov 2027 |
| MDMR-000202 | R-test Dengue NS1 AG Rapid Test | C | Valid to Nov 2027 |
| MDMR-000283 | R-test Dengue NS1 Ag Self Test (Dengue NS1 antigen (DEN1, 2, 3, 4) self… | C | Valid to Oct 2028 |
| MDMR-000268 | R-test FOB Rapid Test (Fecal occult blood (FOB) detection kit) R-37050 | C | Valid to Aug 2028 |
| MDMR-000415 | R-test H. Pylori Ab Rapid Test H. pylori Ab Rapid Test [Sizes: 50 pcs… | C | Valid to Jan 2030 |
| MDMR-000412 | R-Test Malaria Ag Pf/Pan Self-Test Malaria detection kit [Sizes: 01 pcs / pack] | C | Valid to Jan 2030 |
| MDMR-000347 | R-test Malaria Pf/Pan Rapid Test Malaria Antigen Detection Kit (Colloidal Gold) | C | Valid to Aug 2029 |
| MDMR-000201 | R-test Malaria Pf/Pv Ag Rapid Test | C | Valid to Nov 2027 |
| MDMR-000286 | R-test Multi- 5 Drug Panel Rapid Test (Drug of abuse detection kit) | C | Valid to Oct 2028 |
| MDMR-000287 | R-test Multi-10 Drug Panel Rapid Test (Drug of abuse detection kit) | C | Valid to Oct 2028 |
| MDMR-000345 | R-test Respiratory 3-Panel Flu/Covid/RSV Rapid Test Flu A&B, Covid-19, RSV Antigen Detection Kit (Colloidal… | C | Valid to Aug 2029 |
| MDMR-000414 | R-Test RSV Ag Rapid Test RSV detection kit [Sizes: 25 pcs / pack] | C | Valid to Jan 2030 |
| MDMR-000284 | R-test SARS-CoV-2 Ag & Flu A/B Combo Rapid Test (Dengue NS1 antigen (DEN1, 2,… | C | Valid to Oct 2028 |
| MDMR-000200 | R-test Syphilis Ab Rapid Test | C | Valid to Nov 2027 |
| MDMR-000346 | R-test Syphilis Ab Self Test Syphilis Antibodies Detection Kit (Colloidal Gold) | C | Valid to Aug 2029 |
| MDMR-000269 | R-test TB IgG/IgM Rapid Test (IgG, IgM anti-Mycobacterium tuberculosis (M. TB) detection kit) R-34050 | C | Valid to Aug 2028 |
| MDMR-000191 | R-Test Typhoid Ag Rapid Test [R-17050, 50 Tests] | C | Valid to Sep 2027 |
| MDIR-0007176 | Triple Blood Bag | C | Valid to Aug 2029 |
| MDMR-000524 | * GLOW AMH Fluorescence Immunochromatograp hy Kit | B | Valid to May 2030 |
| MDMR-000528 | * GLOW B-HCG Fluorescence Immunochromatograp hy Kit B-HCG Fluorescence Immunochromatograp hy Kit | B | Valid to May 2030 |
| MDMR-000526 | * GLOW CRP Fluorescence Immunochromatograp hy Kit CRP Fluorescence Immunochromatograp hy Kit [40 pcs… | B | Valid to May 2030 |
| MDMR-000525 | * GLOW HbA1c Fluorescence Immunochromatograp hic Kit HbA1c Fluorescence Immunochromatograp hic Kit [40 pcs… | B | Valid to May 2030 |
| MDMR-000521 | * GLOW LH Fluorescence Immunochromatograp hy Kit [40 pcs / pack] | B | Valid to May 2030 |
| MDMR-000529 | * GLOW SAA Fluorescence Immunochromatograp hy Kit SAA Fluorescence Immunochromatograp hy Kit [40 pcs… | B | Valid to May 2030 |
| MDMR-000401 | ALVENTri P Vacuum Blood Collection Tubes | B | Valid to Oct 2029 |
| MDMR-000396 | ALVENTri Vacuum Blood Collection Tubes | B | Valid to Oct 2029 |
| MDMR-000399 | piXi-100 DC Coagulation 2 Test Panel | B | Valid to Oct 2029 |
| MDMR-000398 | piXi-100 DC Coagulation 4 Test Panel | B | Valid to Oct 2029 |
| MDMR-000192 | R-Test H.Pylori Ag Rapid Test [R-16050, 50 Tests] | B | Valid to Sep 2027 |
| MDMR-000205 | R-test hCG Pregnancy Rapid Test | B | Valid to Nov 2027 |
| MDMR-000183 | R-Test HCG Rapid Test Kit (Human Chorionic Gonadotrophin Test Kit) | B | Valid to Jun 2027 |
| MDMR-000348 | R-test Ovulation Midstream Test Ovulation (LH) Midstream Detection Kit (Colloidal Gold) | B | Valid to Aug 2029 |
| MDMR-000349 | R-test Pregnancy Midstream Test Pregnancy (hCG) Midstream Detection Kit (Colloidal Gold) | B | Valid to Aug 2029 |
| MDMR-000397 | staGna-100 Electrolyte 7 Test Panel | B | Valid to Oct 2029 |
| MDMR-000400 | staGna-100 General Chemistry 13 Test Panel | B | Valid to Oct 2029 |
| MDMR-000196 | ViGen Viral Nucleic Acid Auto Extraction Kit [64 Tests per kit] | B | Valid to Oct 2027 |
| MDMR-000413 | ViGen-Totality (Viral DNA/ RNA Auto Extraction Kit) [Sizes: 96 pcs / pack] | B | Valid to Jan 2030 |
| MDME-0000033 | COVID-19 Collection & Transport Kit | A | Renewal passed |
| MDME-0000297 | Glow-100 Fluorescence Immunoassay Analyze | A | Valid to Jan 2030 |
| MDME-0000278 | piXi-100 DC Coagulation Analyzer | A | Valid to Oct 2029 |
| MDME-0000277 | staGna-100 DC Chemistry Analyzer | A | Valid to Oct 2029 |
| MDME-0000021 | Viral Transport Media | A | Renewal passed |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.