M/s. CPC Diagnostics Pvt, Ltd
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 4 |
| Class B | Low–moderate risk | 611 |
| Class C | Moderate–high risk | 134 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
This test kit provides qualitative or semiquantitative in vitro determination of human antibodies of immunoglobulin class IgG against cell nuclei in patient samples to support the diagnosis of many autoimmune diseases, particularly those of…
IMP/IVD/2022/000152 · from GermanyUse for regular maintenance of Chemiluminescence Immunoassay Analyzer
IMP/IVD/2022/000088 · from ChinaThe iFlash-Mycoplasma pn. IgM assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the qualitative determination of IgM antibody to Mycoplasma pn. in human serum and plasma using the iFlash Immunoassay Analyer.
IMP/IVD/2022/000088 · from ChinaThe iFlash-Mycoplasma pn. IgG assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the quantitative determination of IgG antibody to Mycoplasma pn. in human serum and plasma using the iFlash Immunoassay Analyzer.
IMP/IVD/2022/000088 · from ChinaThe iFlash-Chlamydia pn. IgM assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for qualitative determination of IgM antibody to Chlamydia Pneumoniae (Chlamydia pn.) in human serum and plasma using the iFlash Immunoassay A…
IMP/IVD/2022/000088 · from ChinaThe iFlash-Chlamydia pn. IgG assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative determination of IgG antibody to Chlamydia Pneumoniae (Chlamydia pn.) in human serum and plasma using the iFlash Immunoassay …
IMP/IVD/2022/000088 · from ChinaThe iFlash-HSV-1 IgG assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the qualitative determination of IgG antibody to herpes simplex virus-1 (HSV-1) in human serum and plasma using the iFlash Immunoassay Analyzer. T…
IMP/IVD/2022/000088 · from ChinaThe iFlash-CMV IgM assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for qualitative determination of IgM antibody to cytomegalovirus (CMV) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFlash-CMV I…
IMP/IVD/2022/000088 · from ChinaThe iFlash-Toxo IgM assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the qualitative determination of IgM antibody to Toxoplasma gondii (Toxo) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFla…
IMP/IVD/2022/000088 · from ChinaThe iFlash-HSV-2 IgG assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the qualitative determination of IgG antibody to herpes simplex virus-2 (HSV-2) in human serum and plasma using the iFlash Immunoassay Analyzer. T…
IMP/IVD/2022/000088 · from ChinaThe iFlash-HSV-2 IgM assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the qualitative determination of IgM antibody to herpes simplex type 2 virus (HSV-2) in human serum and plasma using the iFlash Immunoassay Analyz…
IMP/IVD/2022/000088 · from ChinaThe iFlash-Toxo IgG assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative determination of IgG antibody to Toxoplasma gondii (Toxo) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFlash-…
IMP/IVD/2022/000088 · from ChinaThe iFlash-CMV IgG assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative determination of IgG antibody to cytomegalovirus (CMV) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFlash-CMV …
IMP/IVD/2022/000088 · from ChinaThe iFlash-Rubella IgG assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative determination of IgG antibody to Rubella virus (RV) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFlash-Rub…
IMP/IVD/2022/000088 · from ChinaThe iFlash-Rubella IgM assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for qualitative determination of IgM antibody to Rubella virus (RV) in human serum and plasma using the iFlash Immunoassay Analyzer. The iFlash-Rube…
IMP/IVD/2022/000088 · from ChinaThe iFlash-HSV-1 IgM assay is a paramagnetic particle chemiluminescent immunoassay (CLIA) for the qualitative determination of IgM antibody to herpes simplex virus-1 (HSV-1) in human serum and plasma using the iFlash Immunoassay Analyzer. T…
IMP/IVD/2022/000088 · from ChinaThe Rheumatoid Arthritis Multi Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for RF, RF IgG, RF IgM and anti-CCP on the iFlash systems
IMP/IVD/2022/000088 · from ChinaThe MPO IgG Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for MPO IgG on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe Beta2-Glycoprotein I IgM Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for ?2-Glycoprotein I IgM on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe Cardiolipin IgG Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for Cardiolipin IgG on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe Anti-Cardiolipin Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for Anti-Cardiolipin on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe Beta2-Glycoprotein I IgG Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for ?2-Glycoprotein I IgG on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe dsDNA IgG Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for dsDNA IgG antibodies on the iFlash systems
IMP/IVD/2022/000088 · from ChinaThe ANA Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for Anti-nuclear antibody (ANA) on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe Anti-beta2-Glycoprotein I Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for Anti-?2-Glycoprotein I on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe PR3 IgG Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for PR3 IgG (Proteinase 3 IgG) on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaThe Cardiolipin IgM Control is intended for use as an assayed quality control sample to monitor the performance of the immunoassays for Cardiolipin IgM on the iFlash systems.
IMP/IVD/2022/000088 · from ChinaUsed for measuring the accurate electrolyte composition
IMP/IVD/2021/000364 · from JapanFor use in the iFlash Immunoassay Analyzer to dilute the determinand
IMP/IVD/2022/000088 · from ChinaFor use in the iFlash Immunoassay Analyzer to dilute the determinand
IMP/IVD/2022/000088 · from ChinaThe VISION ESR Analyze is a fully-automated ESR analyzer intended for determination of Erythrocyte Sedimentation Rate of whole blood taken from clinical settings. The VISION ESR Analyzer is a clinical diagnostic instrument for determining…
IMP/IVD/2022/000088 · from ChinaThe iFlash chemiluminescence immunoassay analyzer is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human serum, plasma, or urine samples taken from clinical s…
IMP/IVD/2022/000088 · from ChinaIN- VITRO DIAGNOSTIC REAGENTS FOR AUTOIMMUNE NEUROLOGICAL DISEASES.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF AUTOIMMUNE NEUROLOGICAL DISEASES.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR THE DIAGNOSIS OF DIABETES MELLITUS
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGNETS FOR THE DIAGNOSIS OF WEGENER'S GRANULOMATOSIS, MIRCOSCOPIC POLYANGITIS, RAPID PROGRESSIVE GLOMERULONEPHRITIS GOODPASTURE SYNDROME AND OTHER FORMS OF VASCULITIS
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF PERNICIOUS ANEMIA CHRONIC ATROPHIC GASTRITIS.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR AUTOIMMUNE DISEASES
IMP/IVD/2022/000152 · from GermanyIn-vitro Diagnostic reagents for Autoimmune Diseases.
IMP/IVD/2022/000152 · from GermanyIN-VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF NEUROMYELITIS OPTICA ( NMO, OPTICOSPINAL ENCEPHALOMYELITIS, DEVIC'S SYNDROME)
IMP/IVD/2022/000152 · from GermanyIn-vitro Diagnostic reagents for Autoimmune Diseases.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR AUTO IMMUNE LIVER DISEASES.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR AUTOIMMUNE LIVER DISEASES
IMP/IVD/2022/000152 · from GermanyIn-vitro Diagnostic reagents for Autoimmune Diseases.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF AUTOIMMUNE NEUROLOGICAL DISEASES.
IMP/IVD/2022/000152 · from GermanyIn-vitro Diagnostic reagents for the detection of Pemphigus foliaceus, pemphigus vulgaris.
IMP/IVD/2022/000152 · from GermanyIn-vitro Diagnostic reagents for the detection of Pemphigus foliaceus, pemphigus vulgaris.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF AUTOIMMUNE ENCEPHALITIS.
IMP/IVD/2022/000152 · from GermanyIn-vitro Diagnostic reagents for Autoimmune Diseases.
IMP/IVD/2022/000152 · from GermanyIN- VITRO DIAGNOTIC REAGENTS FOR AUTOIMMNUE DISEASES
IMP/IVD/2022/000152 · from GermanyGlobal footprint
Cross-railThe same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.
No FDA clearances linked — India-domestic footprint.
Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.