Importer / authorised agent · Tamil Nadu · India

M/s. CPC Diagnostics Pvt, Ltd

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
749
Manufacturing
0
Import
749
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices4
Class BLow–moderate risk611
Class CModerate–high risk134
Class D (high risk)Highest-risk devices0

CDSCO device licences

IIFT: ANA Mosaic 1A EUROPattern · Class BIMPORT · 2026-04-27

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 Germany
iFlash-Cleaning Solution · Class AIMPORT · 2024-02-20

Use for regular maintenance of Chemiluminescence Immunoassay Analyzer

IMP/IVD/2022/000088 · from China
Mycoplasma pn. IgM · Class BIMPORT · 2024-02-06

The 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 China
Mycoplasma pn. IgG · Class BIMPORT · 2024-02-06

The 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 China
Chlamydia pn. IgM · Class CIMPORT · 2024-02-06

The 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 China
Chlamydia pn. IgG · Class CIMPORT · 2024-02-06

The 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 China
HSV-1 IgG · Class CIMPORT · 2023-11-20

The 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 China
CMV IgM · Class CIMPORT · 2023-11-20

The 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 China
Toxo IgM · Class CIMPORT · 2023-11-20

The 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 China
HSV-2 IgG · Class CIMPORT · 2023-11-20

The 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 China
HSV-2 IgM · Class CIMPORT · 2023-11-20

The 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 China
Toxo IgG · Class CIMPORT · 2023-11-20

The 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 China
CMV IgG · Class CIMPORT · 2023-11-20

The 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 China
Rubella IgG · Class CIMPORT · 2023-11-20

The 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 China
Rubella IgM · Class CIMPORT · 2023-11-20

The 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 China
HSV-1 IgM · Class CIMPORT · 2023-11-20

The 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 China
Rheumatoid Arthritis Multi Control · Class BIMPORT · 2023-02-23

The 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 China
MPO IgG Control · Class BIMPORT · 2023-02-23

The 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 China
Beta2-Glycoprotein I IgM Control · Class BIMPORT · 2023-02-23

The 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 China
Cardiolipin IgG Control · Class BIMPORT · 2023-02-23

The 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 China
Anti-Cardiolipin Control · Class BIMPORT · 2023-02-23

The 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 China
Beta2-Glycoprotein I IgG Control · Class BIMPORT · 2023-02-23

The 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 China
dsDNA IgG Control · Class BIMPORT · 2023-02-23

The 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 China
ANA Control · Class BIMPORT · 2023-02-23

The 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 China
Anti-beta2-Glycoprotein I Control · Class BIMPORT · 2023-02-23

The 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 China
PR3 IgG Control · Class BIMPORT · 2023-02-23

The 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 China
Cardiolipin IgM Control · Class BIMPORT · 2023-02-23

The 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 China
Electrolyte Analyzer · Class AIMPORT · 2023-01-18

Used for measuring the accurate electrolyte composition

IMP/IVD/2021/000364 · from Japan
Sample Diluent B · Class BIMPORT · 2022-12-05

For use in the iFlash Immunoassay Analyzer to dilute the determinand

IMP/IVD/2022/000088 · from China
Sample Diluent H · Class BIMPORT · 2022-12-05

For use in the iFlash Immunoassay Analyzer to dilute the determinand

IMP/IVD/2022/000088 · from China
Automated ESR Analyzer · Class AIMPORT · 2022-12-05

The 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 China
Fully Automated Chemiluminescense Immunoassay analyser · Class AIMPORT · 2022-12-05

The 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 China
ANTI- GLUTAMATE RECEPTOR (TYPE NMDA) IIFT EURO PATTERN · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR AUTOIMMUNE NEUROLOGICAL DISEASES.

IMP/IVD/2022/000152 · from Germany
ANTI-IgLON FAMILY MEMBER 5 (IgLON5) IIFT · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF AUTOIMMUNE NEUROLOGICAL DISEASES.

IMP/IVD/2022/000152 · from Germany
ANTI- GAD ELISA (IgG) · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR THE DIAGNOSIS OF DIABETES MELLITUS

IMP/IVD/2022/000152 · from Germany
ANTI- GBM ELISA (IgG) · Class BIMPORT · 2022-07-18

IN- 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 Germany
:ANTI- INTRINSIC FACTOR IIFT · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF PERNICIOUS ANEMIA CHRONIC ATROPHIC GASTRITIS.

IMP/IVD/2022/000152 · from Germany
ANTI-F-ACTIN IIFT · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR AUTOIMMUNE DISEASES

IMP/IVD/2022/000152 · from Germany
Anti-ENA ProfilePlus 2 ELISA (IgG) · Class BIMPORT · 2022-07-18

In-vitro Diagnostic reagents for Autoimmune Diseases.

IMP/IVD/2022/000152 · from Germany
ANTI- AQUAPORIN - 4- IIFT EUROPATTERN · Class BIMPORT · 2022-07-18

IN-VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF NEUROMYELITIS OPTICA ( NMO, OPTICOSPINAL ENCEPHALOMYELITIS, DEVIC'S SYNDROME)

IMP/IVD/2022/000152 · from Germany
Anti-ENA SLE Profile 2 ELISA (IgG) · Class BIMPORT · 2022-07-18

In-vitro Diagnostic reagents for Autoimmune Diseases.

IMP/IVD/2022/000152 · from Germany
ANTI- F- ACTIN IIFT EURO PATTERN · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR AUTO IMMUNE LIVER DISEASES.

IMP/IVD/2022/000152 · from Germany
ANTI-LKM-1 ELISA (IgG) · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR AUTOIMMUNE LIVER DISEASES

IMP/IVD/2022/000152 · from Germany
Anti-DFS70 ELISA (IgG) · Class BIMPORT · 2022-07-18

In-vitro Diagnostic reagents for Autoimmune Diseases.

IMP/IVD/2022/000152 · from Germany
ANTI- DNER IIFT · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF AUTOIMMUNE NEUROLOGICAL DISEASES.

IMP/IVD/2022/000152 · from Germany
Anti-Desmoglein 1 ELISA (IgG) · Class BIMPORT · 2022-07-18

In-vitro Diagnostic reagents for the detection of Pemphigus foliaceus, pemphigus vulgaris.

IMP/IVD/2022/000152 · from Germany
Anti-Desmoglein 3 ELISA (IgG) · Class BIMPORT · 2022-07-18

In-vitro Diagnostic reagents for the detection of Pemphigus foliaceus, pemphigus vulgaris.

IMP/IVD/2022/000152 · from Germany
ANTI-- DPPX IIFT · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOSTIC REAGENTS FOR THE DETECTION OF AUTOIMMUNE ENCEPHALITIS.

IMP/IVD/2022/000152 · from Germany
:ANA Screen 9 ELISA (IgG) · Class BIMPORT · 2022-07-18

In-vitro Diagnostic reagents for Autoimmune Diseases.

IMP/IVD/2022/000152 · from Germany
AMA/ ASMA IIFT (KR/SR) EURO PATTERN · Class BIMPORT · 2022-07-18

IN- VITRO DIAGNOTIC REAGENTS FOR AUTOIMMNUE DISEASES

IMP/IVD/2022/000152 · from Germany

Global footprint

Cross-rail

The 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.

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