Domestic manufacturer · Tamil Nadu · India

Genuine Biosystem Private Limited

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
454
Manufacturing
454
Import
0
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices25
Class BLow–moderate risk340
Class CModerate–high risk59
Class D (high risk)Highest-risk devices30

CDSCO device licences

Clinical chemistry analyser - (Semi automated) · Class AMFG · 2024-12-12

Clinical Chemistry Analyzer - (Semi-Automated) intended to be used for the qualitative and/or quantitative determination of one or multiple clinical chemistry parameters like (Glucose, Cholesterol, Triglycerides, Albumin, total protein, Cal…

MFG/IVD/2018/000004 · Tamil Nadu
Ion-selective Analyser · Class AMFG · 2024-12-12

Ion-selective Analyser intended to be used for the quantitative measurement of electrolytes and/or other ions like Na+ (sodium), K+ (Potassium) Cl- (chloride), Calcium (Ca+), pH, Mg+ (magnesium), Lithium in human specimens like whole blood …

MFG/IVD/2018/000004 · Tamil Nadu
Erythrocyte sedimentation rate (ESR) analyser · Class AMFG · 2024-12-12

Erythrocyte sedimentation rate (ESR) analyser is the medical device, intended for the quantitative measurement of sedimentation rate of human red blood cells.

MFG/IVD/2018/000004 · Tamil Nadu
Fluorescent Immunoassay analyzer · Class AMFG · 2024-12-12

Fluorescent Immunoassay analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or of various biological markers like ASO, CRP. RF, microalbuminurea, hSCRP, IgE, D-Dimer, Ferritin, T3, T4,…

MFG/IVD/2018/000004 · Tamil Nadu
Blood coagulation analyser · Class AMFG · 2024-12-12

Blood Coagulation Analyzer intended to be used for the qualitative and/or of quantitative in vitro determination of one or multiple coagulation components involved in hemostasis like Prothrombin Time, partial thromboplastin, TT, Fibrinogen,…

MFG/IVD/2018/000004 · Tamil Nadu
Nephelometry Immunoassay Analyser · Class AMFG · 2024-12-12

Nephelometry Immunoassay Analyser intended to be used for qualitative and/or quantitative in vitro determination of chemical and/or of various biological markers like ASO, CRP, RF, microlabuminurea, Hba1c, C3,C4,IgA, IgM,IgG, IgE, Anti-CCP,…

MFG/IVD/2018/000004 · Tamil Nadu
Clinical chemistry analyzer ( Fully Automated) · Class AMFG · 2024-12-12

Clinical Chemistry Analyzer - (Fully Automated) intended to be used for the qualitative and/or quantitative determination of one or multiple clinical chemistry parameters like (Glucose, Cholesterol, Triglycerides, Albumin, total protein, Ca…

MFG/IVD/2018/000004 · Tamil Nadu
High Performance Liquid Chromatography (HPLC) analyser · Class AMFG · 2024-12-12

High Performance Liquid Chromatography (HPLC) analyser is the medical device intended to use for quantitative analysis of HbA1C in human whole blood sample

MFG/IVD/2018/000004 · Tamil Nadu
Chemiluminescent Immunoassay analyser · Class AMFG · 2024-12-12

Chemiluminescent Immunoassay analyzer is the medical device, intended to use for Qualitative and or quantitative analysis of Invitro determination of chemical and/or biological makers like such as T3,T4, TSH, Free T3, Free T4, FSH, LH, Prol…

MFG/IVD/2018/000004 · Tamil Nadu
Microplate Washer Automated · Class AMFG · 2024-12-12

Microplate Washer Automated intended to be used for washing microplates which is the one of the protocol to do washing as per various ELISA kits assay procotol like T3, T4, TSH, LH, progesterone, testerone, HIV, HBsAg, HCV, etc., in all of …

MFG/IVD/2018/000004 · Tamil Nadu
Blood cell count analyser - (3 Part differential) · Class AMFG · 2024-12-12

Blood Cell counter analyzer - (3- part differential) is a quantitative multiparameter automated hematology analyzer intended for Invitro diagnostic use in screening patient populations found in clinical laboratories. The parameters in whole…

MFG/IVD/2018/000004 · Tamil Nadu
Enzyme Immunoassay (EIA) analyser · Class AMFG · 2024-12-12

Enzyme Immunoassay (EIA) analyser consists of holder for microplate 96 wells plates to record the absorbance/numerical values of microplates of various immunological assays like T3, T4, TSH, fT3, fT4, FSH, LH, Prolactin, progesterone, testo…

MFG/IVD/2018/000004 · Tamil Nadu
Urine Analyser · Class AMFG · 2024-12-12

Urine Analyzer intended to be used for the qualitative and/or quantitative invitro determination of various chemical and cellular constituents like Glucose, ketone, protein, specific gravity, pH, Urobilinogen, Blood, Leukocytes, Bilirubin, …

MFG/IVD/2018/000004 · Tamil Nadu
Blood cell count analyser - (5 Part differential) · Class AMFG · 2024-12-12

Blood Cell counter analyzer - (5- part differential) is a quantitative multiparameter automated hematology analyzer intended for Invitro diagnostic use in screening patient populations found in clinical laboratories. The parameters in whole…

MFG/IVD/2018/000004 · Tamil Nadu
Anti-Neutrophil Cytoplasmic Antibodies (Myeloperoxidase ) (P-ANCA) CLIA test kit · Class BMFG · 2024-08-02

The anti-neutrophil cytoplasmic antibodies (MPO) (P-ANCA) CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of anti-myloperoxidase antibodies in human serum. anti-neutrophil cytoplasmic antibodie…

MFG/IVD/2018/000004 · Tamil Nadu
Myoglobin CLIA test Kit · Class BMFG · 2024-08-02

The Myoglobin CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of MYOGLOBIN in human serum.

MFG/IVD/2018/000004 · Tamil Nadu
Anti Neutrophil Cytoplasmic Antibodies (Protease 3) (C-ANCA) CLIA test ki · Class BMFG · 2024-08-02

The Anti-Neutrophil Cytoplasmic Antibodies (PR3) (C-ANCA) CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of anti-PR3 antibodies in human serum. ANTI-PR3 is to aid in the Wegener's granuloma (W…

MFG/IVD/2018/000004 · Tamil Nadu
Anti thyroid stimulating hormone receptor (anti-TSHR) CLIA test kit · Class BMFG · 2024-08-02

The Anti thyroid stimulating hormone receptor is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of antibody to thyrotropin receptor (Anti-TSHR) in human serum. ANTI TSHR determination is used as an aid in the …

MFG/IVD/2018/000004 · Tamil Nadu
Interleukin-6 (IL-6) CLIA test kit · Class BMFG · 2024-08-02

The IL-6 is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of Interleukin- 6 (IL-6) in human serum. This test is used in the monitoring of body?s immune status and inflammatory response. This test is intended …

MFG/IVD/2018/000004 · Tamil Nadu
CKMB CLIA test kit · Class BMFG · 2024-08-02

The CKMB CLIA Test kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of The MB Isoenzyme of Creatine Kinase (CK-MB) in human serum. This test is an aid in the diagnosis of myocardial infarction. This test …

MFG/IVD/2018/000004 · Tamil Nadu
Anti-Cyclic Citrullinated Peptide Antibodies (Anti -CCP) CLIA test kit · Class BMFG · 2024-08-02

The Anti-cyclic Citrullinated peptide (CCP) Antibodies CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of Anti-cyclic Citrullinated Peptide Antibody in human serum. This test is an aid in the d…

MFG/IVD/2018/000004 · Tamil Nadu
Insulin CLIA test kit · Class BMFG · 2024-08-02

The INSULIN CLIA TEST KIT is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of INSULIN in human serum.

MFG/IVD/2018/000004 · Tamil Nadu
Anti Thyroid gland antibody (Anti-TPO) CLIA test kit · Class BMFG · 2024-08-02

Antithyroid Gland antibodies Test kit is a Medical Device for the screening of auto antibodies to Thyroid Gland antigens in human specimen. IMMUNOCHEMI Antithyroid gland antibodies CLIA Test Kit is a Chemiluminescent Microparticle Immunoass…

MFG/IVD/2018/000004 · Tamil Nadu
C-Peptide CLIA test kit · Class BMFG · 2024-08-02

The C-Peptide CLIA Test Kit is a chemiluminescent immunoassay (CLIA) for the quantitative in vitro detection of C PEPTIDE in human serum.

MFG/IVD/2018/000004 · Tamil Nadu
Para thyroid hormone (PTH) CLIA test kit · Class BMFG · 2024-08-02

The Parathyroid Hormone Test is a chemiluminescent immunoassay(CLIA) for the quantitative in vitro detection of Intact Parathyroid Hormone in human serum. This assay is intended to be used to aid in the differential diagnosis of hyperparath…

MFG/IVD/2018/000004 · Tamil Nadu
Estradiol (E2) CLIA test kit · Class BMFG · 2024-08-02

The Estradiol Hormone CLIA Test Kit is a Chemiluminescent Immunoassay (CLIA) for the quantitative in vitro detection of E2 in human serum.

MFG/IVD/2018/000004 · Tamil Nadu
Ferritin CLIA test kit · Class BMFG · 2024-08-02

The Ferritin CLIA Test Kit is a chemiluminescent immunoassay (CLIA)for the quantitative in vitro detection of FERRITIN in human serum.

MFG/IVD/2018/000004 · Tamil Nadu
Total T3 (Triiodothyronine) TT3 CLIA test kit · Class BMFG · 2024-07-01

Total T3 (Triiodothyronine) TT3 CLIA test kit is the medical device, intended for the quantitative determination of Total T3 (Triiodothyronine) TT3 by chemiluminescence immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Follicle Stimulating Hormone (FSH) CLIA test kit · Class BMFG · 2024-07-01

Follicle Stimulating Hormone (FSH) CLIA test kit is the medical device intended for the quantitative determination of Follicle Stimulating Hormone (FSH) by chemiluminescent immunoassay (CLIA) method in human specimen

MFG/IVD/2018/000004 · Tamil Nadu
Free triiodothyronine (fT3) CLIA test kit · Class BMFG · 2024-07-01

Free triiodothyronine (fT3) CLIA test kit is the medical device intended for the quantitative determination of Free triiodothyronine (fT3) by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Total T4 (Thyroxine) TT4 CLIA test kit · Class BMFG · 2024-07-01

Total T4 (Thyroxine) TT4 CLIA test kit is the medical device intended for the quantitative determination of Total T4 (Thyroxine) TT4 by chemiluminescence immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Prolactin CLIA test kit · Class BMFG · 2024-07-01

Prolactin CLIA test kit is the medical device intended for the quantitative determination of Prolactin by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Thyroid stimulating hormone (TSH) CLIA test kit · Class BMFG · 2024-07-01

Thyroid stimulating hormone (TSH) CLIA test kit is the medical device intended for the quantitative determination of Thyroid stimulating hormone by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Progesterone CLIA test kit · Class BMFG · 2024-07-01

Progesterone CLIA test kit is the medical device intended for the quantitative determination of progesterone by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Testosterone CLIA test kit · Class BMFG · 2024-07-01

Testosterone CLIA test kit is the medical device intended for the quantitative determination of Testosterone by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Luteinizing Hormone (LH) CLIA test kit · Class BMFG · 2024-07-01

Luteinizing Hormone (LH) CLIA test kit is the medical device intended for the quantitative determination of Luteinizing Hormone (LH) by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Free T4 (Thyroxine) fT4 CLIA test kit · Class BMFG · 2024-07-01

Free T4 (Thyroxine) fT4 CLIA test kit is the medical device intended for the quantitative determination of Free T4 (Thyroxine) fT4 by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Anti Mullerion hormone (AMH) CLIA test kit · Class BMFG · 2024-07-01

Anti Mullerion hormone (AMH) CLIA test kit is the medical device intended for the quantitative determination of Anti Mullerion hormone (AMH) by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Vitamin D (25-OH Vitamin-D) CLIA Test Kit · Class BMFG · 2024-07-01

Vitamin D (25-OH Vitamin-D) CLIA test kit is the medical device intended for the quantitative determination of Vitamin D (25-OH Vitamin-D) by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Vitamin B12 CLIA test kit · Class BMFG · 2024-07-01

Vitamin B12 CLIA test kit is the medical device intended for the quantitative determination of Vitamin B12 by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Anti Thyroglobulin (Anti-TG) CLIA test kit · Class BMFG · 2024-07-01

Anti Thyroglobulin (Anti-TG) CLIA test kit is the medical device intended for the quantitative determination of Anti Thyroglobulin (Anti-TG) by chemiluminescent immunoassay (CLIA) method in human specimen.

MFG/IVD/2018/000004 · Tamil Nadu
Anti Mullerion Hormone (AMH) ELISA kit · Class BMFG · 2024-01-22

An AMH kit is a medical device, intended for the estimation of Anti Mullerion Hormone (AMH) in Serum

MFG/IVD/2018/000004 · Tamil Nadu
Folate ELISA kit · Class BMFG · 2024-01-22

A Folate kit is a medical device, intended for the estimation of Folate in serum

MFG/IVD/2018/000004 · Tamil Nadu
Chloride kit · Class BMFG · 2024-01-22

A Chloride kit is a medical device, intended for the estimation of chloride in serum/urine

MFG/IVD/2018/000004 · Tamil Nadu
CKNAC Kit · Class BMFG · 2024-01-22

A CKNAC kit is a medical device, intended for the estimation of enzyme creatine kinase total (CKNAC) in serum

MFG/IVD/2018/000004 · Tamil Nadu
Micro protein Kit · Class BMFG · 2024-01-22

A Micro protein kit is a medical device, intended for the estimation of micro protein in urine

MFG/IVD/2018/000004 · Tamil Nadu
C-peptide ELISA kit · Class BMFG · 2024-01-22

A C-Peptide kit is a medical device, intended for the estimation of C-peptide in serum

MFG/IVD/2018/000004 · Tamil Nadu
Potassium kit · Class BMFG · 2024-01-22

A potassium kit is a medical device, intended for the estimation of potassium in serum/urine

MFG/IVD/2018/000004 · Tamil Nadu
Sodium kit · Class BMFG · 2024-01-22

A sodium is a medical device, intended for the estimation of sodium in serum/urine

MFG/IVD/2018/000004 · Tamil Nadu
Urea (Kin.) kit · Class BMFG · 2024-01-22

An Urea kit is a medical device, intended for the estimation of Urea in Serum

MFG/IVD/2018/000004 · Tamil Nadu

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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