Domestic manufacturer · Uttar Pradesh · India

BIOGENIX INC. PVT. LTD.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
503
Manufacturing
500
Import
3
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices54
Class BLow–moderate risk422
Class CModerate–high risk23
Class D (high risk)Highest-risk devices4

CDSCO device licences

Hemoglobin Test Strips · Class BMFG · 2026-01-07

This test is for the quantitative determination of hemoglobin (Hb) and calculated hematocrit (Hct) in capillary and venous whole blood.

MFG/IVD/2020/000082 · Uttar Pradesh
Chikungunya Rapid Test · Class BMFG · 2026-01-05

For detection of Chikungunya IgM virus in human serum and plasma

MFG/IVD/2020/000082 · Uttar Pradesh
Scrub Typhus IgG ELISA Kit · Class BMFG · 2026-01-05

The Scrub Typhus Elisa kit for IgG Test is a qualitative ELISA for the detection of IgG antibodies to O. tsutsugamushi (OT) in serum.

MFG/IVD/2020/000082 · Uttar Pradesh
Scrub Typhus IgM ELISA Kit · Class BMFG · 2026-01-05

The Scrub Typhus Elisa kit for IgM Test is a qualitative ELISA for the detection of IgM antibodies to O. tsutsugamushi (OT) in serum.

MFG/IVD/2020/000082 · Uttar Pradesh
Dengue IgG/IgM Rapid Test · Class BMFG · 2026-01-05

For detection of Dengue IgG/IgM virus in human serum and plasma

MFG/IVD/2020/000082 · Uttar Pradesh
TYPHOID IgG/IgM Rapid Test · Class BMFG · 2026-01-05

For detection of Typhoid IgG/IgM virus in human serum and plasma

MFG/IVD/2020/000082 · Uttar Pradesh
ASO (Anti Streptolysin O) Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

ASO is a fluorescence Immunoassay for the quantitative determination of Anti Streptolysin O (ASO) in human serum / plasma. It is useful as an aid in management and monitoring of scarlet fever, rheumatic fever and post infectious glomerulone…

MFG/IVD/2020/000082 · Uttar Pradesh
HbA1c (Glycated hemoglobin) Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

HbA1c Card is a rapid and sensitive immunoassay for the quantitative determination of HbA1c (Glycated hemoglobin) in human whole blood with Analyzer. The test is used for routine monitoring of long term glycemic status in patient with diabe…

MFG/IVD/2020/000082 · Uttar Pradesh
Anti-Cyclic Citrullinated Peptide (Anti CCP) Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Anti-CCP is fluorescence Immunoassay (FIA) for the qualitative or semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides (CCP) in human whole blood/serum/plasma. It is useful as an aid in the diagnosis …

MFG/IVD/2020/000082 · Uttar Pradesh
TSH (Thyroid stimulating hormone)Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

TSH Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of TSH (Thyroid stimulating hormone) in human serum and plasma.

MFG/IVD/2020/000082 · Uttar Pradesh
PRL (Prolactin) Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

PRL is a fluorescence Immunoassay for the quantitative determination of PRL in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of hypothalamic-pituitary disorders.

MFG/IVD/2020/000082 · Uttar Pradesh
LH Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

LH is fluorescence Immunoassay for the quantitative determination of Luteinizing hormone (LH) in human serum/plasma. It is useful as an aid in management and monitoring of determination of evaluating fertility issues, function of reproducti…

MFG/IVD/2020/000082 · Uttar Pradesh
Dengue IgG/IgM Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Dengue IgG/IgM is a fluorescence Immunoassay (FIA) for the qualitative determination of IgG/IgM antibodies against dengue virus in human whole blood/serum/plasma. It is useful as an aid in screening of Dengue virus infection.

MFG/IVD/2020/000082 · Uttar Pradesh
?-HCG Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

?-HCG is fluorescence Immunoassay for the quantitative determination of ?-HCG in human whole blood/serum /plasma. It is useful as an aid in management and monitoring of beta human chorionic gonadotropin (?-hCG) level in human.

MFG/IVD/2020/000082 · Uttar Pradesh
BRUCELLA ANTIBODY ELISA KIT · Class BMFG · 2025-12-20

Biogenix Brucella Antibody ELISA Kit are quantitative and qualitative tests for detection of antibodies in serum and plasma directed against Brucella species for sue in diagnostic procedures.

MFG/IVD/2020/000082 · Uttar Pradesh
Total IgE Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Total IgE is a fluorescence immunoassay (FIA) for the quantitative determination of total IgE in human whole blood/serum/ plasma. It is useful as an aid in diagnosis and management of allergic disease.

MFG/IVD/2020/000082 · Uttar Pradesh
SALMONELLA ANTIBODY ELISA TEST · Class BMFG · 2025-12-20

The Salmonella antibody ELISA kit is a specific and sensitive assay for the detection of Salmonella antibodies in chicken sera.

MFG/IVD/2020/000082 · Uttar Pradesh
Chemiluminescent Immunoassay Analyser · Class AMFG · 2025-12-20

An analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen.

MFG/IVD/2020/000082 · Uttar Pradesh
FMD (FOOT-AND-MOUTH) ANTIBODY ELISA KIT · Class BMFG · 2025-12-20

The Foot-and-mouth disease indirect ELISA Test kit is used for the detection of FMD antibody in animal serum samples.

MFG/IVD/2020/000082 · Uttar Pradesh
CANINE BRUCELLOSIS ANTIBODY ELISA TEST · Class BMFG · 2025-12-20

Canine Brucellosis antibody ELISA kit is for the qualitative detection of specific antibodies present in serum of dogs, other animals and in humans with clinical symptoms consistent with Canine brucellosis.

MFG/IVD/2020/000082 · Uttar Pradesh
BOVINE LEPTOSPIRA ELISA TEST · Class BMFG · 2025-12-20

Bovine Leptospira Antibody Rapid Detection Test is a lateral flow Immuno chromatographic assay for the qualitative detection of Leptospira Specific antibodies in Serum or plasma. It is intended to be used as a screening test and as an aid i…

MFG/IVD/2020/000082 · Uttar Pradesh
Vitamin D Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Vitamin D is a fluorescence Immunoassay (FIA) for the quantitative determination of total 25(OH)D2/D3 level in human serum/plasma. It is useful as an aid in management and monitoring of regulating the concentration of calcium and phosphate …

MFG/IVD/2020/000082 · Uttar Pradesh
T3 (triiodothyronine) test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

T3 Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of total T3 (Triiodothyronine) in human serum and plasma under normal physiological conditions, total T3 only accounts for about 5% of thyroid horm…

MFG/IVD/2020/000082 · Uttar Pradesh
Progesterone Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Progesterone is a fluorescence Immunoassay for the quantitative determination of progesterone in human serum/plasma. It is useful as an aid in management and monitoring of the cause of infertility, track ovulation, diagnose an ectopic or fa…

MFG/IVD/2020/000082 · Uttar Pradesh
Myoglobin Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Myoglobin is fluorescence Immunoassay (FIA) for the quantitative determination of Myoglobin in human whole blood/ serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction

MFG/IVD/2020/000082 · Uttar Pradesh
Microalbumin Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Microalbumin is fluorescence Immunoassay for the quantitative determination of Microalbumin in human urine. It is useful as an aid in management and monitoring of determination of kidney damage from diabetes.

MFG/IVD/2020/000082 · Uttar Pradesh
FSH Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

FSH Plus is fluorescence Immunoassay (FIA) for the quantitative determination of FSH in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of concentration of FSH.

MFG/IVD/2020/000082 · Uttar Pradesh
Ferritin Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Ferritin is fluorescence Immunoassay (FIA) for the quantitative determination of Ferritin in human serum/plasma. It is useful as an aid for quantifying human ferritin.

MFG/IVD/2020/000082 · Uttar Pradesh
Cortisol Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Cortisol is fluorescence Immunoassay (FIA) for the quantitative determination of Cortisol in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of concentration of cortisol.

MFG/IVD/2020/000082 · Uttar Pradesh
CK-MB Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

CK-MB is Dry fluorescence Immunoassay for the quantitative determination of Creatine Kinase Isoenzyme-MB (CK-MB) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardiac infarction (AMI) and…

MFG/IVD/2020/000082 · Uttar Pradesh
Glycated Haemoglobin (HbA1C) analyser · Class AMFG · 2025-12-20

An analyzer intended to be used for the quantitative measurement of Glycated Haemoglobin (HbA1C) in a clinical specimen.

MFG/IVD/2020/000082 · Uttar Pradesh
PARATUBERCULOSIS (PTB) ANTIBODY ELISA KIT · Class BMFG · 2025-12-20

The Biogenix Mycobacterium avium subspecies paratuberculosis (MAP/paraTB) indirect ELISA kit is for the qualitative detection of specific antibodies present in serum of cattle, buffaloes, sheep, goat and camels with clinical symptoms consis…

MFG/IVD/2020/000082 · Uttar Pradesh
Testosterone Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

Testosterone is fluorescence Immunoassay for the quantitative determination of Testosterone in human serum/plasma. It is useful as an aid in management and monitoring of androgen level

MFG/IVD/2020/000082 · Uttar Pradesh
AMH (anti-mullerian hormone) Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

AMH Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of AMH (anti-mullerian hormone) in serum.AMH is a member of the transforming growth factor beta super family, which is a disaccharide protein comp…

MFG/IVD/2020/000082 · Uttar Pradesh
Blood Gas Analyser · Class AMFG · 2025-12-20

An analyser intended to be used for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and /or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters in a clinical speci…

MFG/IVD/2020/000082 · Uttar Pradesh
PESTE DES PETITS RUMINANT VIRUS (PPRV) ELISA TEST · Class BMFG · 2025-12-20

PPRV indirect ELISA kit is for the qualitative detection of specific antibodies present in serum of cattle, buffaloes, sheep, goat and humans Serum.

MFG/IVD/2020/000082 · Uttar Pradesh
HOMOCYSTEIN TEST REAGENTS · Class BMFG · 2025-12-20

Homocystein test reagent/kit is a medical device intended for the estimation of Homocystein in blood/body fluids.

MFG/IVD/2020/000082 · Uttar Pradesh
THEILERIA ELISA TEST · Class BMFG · 2025-12-20

Theileria ELISA is for the qualitative detection of antibodies to Theileria in serum/Plasma as an aid in the clinical laboratory diagnosis of catteles with clinical symptoms consistent with leptospirosis.

MFG/IVD/2020/000082 · Uttar Pradesh
Chikungunya IgM Ab ELISA Kit · Class BMFG · 2025-12-20

Chikungunya IgM ELISA is designed for in vitro qualitative detection of Chikungunya IgM in human serum or plasma of collected blood samples suspected for Chikungunya.

MFG/IVD/2020/000082 · Uttar Pradesh
Blood Culture Analyser · Class AMFG · 2025-12-20

An analyzer intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism.

MFG/IVD/2020/000082 · Uttar Pradesh
FMD (FOOT-AND-MOUTH) DIVA ANTIBODY ELISA KIT · Class BMFG · 2025-12-20

The Foot-and-mouth disease DIVA ELISA Test kit is used for the detection of FMD vaccinated and non-vaccinated animal serum samples with 3ABC antigen.

MFG/IVD/2020/000082 · Uttar Pradesh
CANINE LEPTOSPIRA ELISA TEST · Class BMFG · 2025-12-20

Canine Leptospira ELISA is for the qualitative detection of antibodies to Canine leptospira in serum as an aid in the clinical laboratory diagnosis of dogs with clinical symptoms consistent with leptospirosis.

MFG/IVD/2020/000082 · Uttar Pradesh
Sickle Cell Rapid Test · Class BMFG · 2025-12-20

The Sickle cell test is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, S, and C using fingerstick or venipuncture whole blood samples.

MFG/IVD/2020/000082 · Uttar Pradesh
BOVINE TUBERCULOSIS (TB) ANTIBODY ELISA KIT · Class BMFG · 2025-12-20

The Biogenix Bovine Tuberculosis ELISA is for the qualitative detection of antibodies to Bovine Tuberculosis in serum as an aid in the clinical laboratory diagnosis of cattles with clinical symptoms consistent with leptospirosis.

MFG/IVD/2020/000082 · Uttar Pradesh
ANTHRAX ANTIBODY ELISA TEST · Class BMFG · 2025-12-20

The Anthrax antibody ELISA kit is a specific and sensitive assay for the detection of Anthrax antibodies in sera.

MFG/IVD/2020/000082 · Uttar Pradesh
Luteinizing Hormone (LH) Rapid Test · Class BMFG · 2025-12-20

LH rapid test is an in-vitro immunochromatographic one step assay designed for qualitative determination of Luteinizing Hormone in urine to predict time of ovulation.

MFG/IVD/2020/000082 · Uttar Pradesh
Sickle Cell Solubility Test Kit · Class BMFG · 2025-12-20

Test for qualitative determination of sickling hemoglobin in whole blood by solubility test method

MFG/IVD/2020/000082 · Uttar Pradesh
T4 test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

T4 Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of total T4 (Thyroxine) in human serum and plasma under normal physical conditions. It can be used in the monitoring of hyperthyroidism and hypothy…

MFG/IVD/2020/000082 · Uttar Pradesh
RF (Rheumatoid Factor) Test Kit (Dry Fluorescence Immunoassay) · Class BMFG · 2025-12-20

RF IgM is a fluorescence Immunoassay for the quantitative determination of RF IgM in human whole blood / serum / plasma. It is useful as an aid in management and monitoring of rheumatoid arthritis.

MFG/IVD/2020/000082 · Uttar Pradesh
Fluorescent Immunoassay Analyser (TRFIA) · Class AMFG · 2025-12-20

An analyzer intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen.

MFG/IVD/2020/000082 · Uttar Pradesh

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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