Domestic manufacturer · Gujarat · India

Vector Biotek Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
637
Manufacturing
561
Import
76
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices74
Class BLow–moderate risk548
Class CModerate–high risk15
Class D (high risk)Highest-risk devices0

CDSCO device licences

Immunofluorescence Quantitative Analyzer · Class AIMPORT · 2026-05-04

A device used to measures the volume of the antigen/antibody present in the components of body fluids.

IMP/IVD/2019/000410 · from China
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
HPLC Analyzer · Class AMFG · 2026-01-30

Analyzer uses ion exchange high performance liquid chromatography for quantitative determination of the content of glycated hemoglobin.

MFG/IVD/2020/000007 · Gujarat
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
5 Part Hematology Analyzer for veterinary · Class AMFG · 2026-01-30

5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination

MFG/IVD/2020/000007 · Gujarat
Probe Cleaner · Class BMFG · 2026-01-30

Cleaner for Unikon 3 3-part differential blood cell counters

MFG/IVD/2020/000007 · Gujarat
5 Part Hematology Analyzer · Class AMFG · 2026-01-30

5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination

MFG/IVD/2020/000007 · Gujarat
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
5 Part Hematology Analyzer · Class AMFG · 2026-01-30

5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination

MFG/IVD/2020/000007 · Gujarat
5 Part Hematology Analyzer · Class AMFG · 2026-01-30

5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination

MFG/IVD/2020/000007 · Gujarat
Diluent · Class BMFG · 2026-01-30

Diluent for Unikon 3 3-part differential blood cell counters

MFG/IVD/2020/000007 · Gujarat
Lyse · Class BMFG · 2026-01-30

Lyse for Unikon 3 3-part differential blood cell counters

MFG/IVD/2020/000007 · Gujarat
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
Auto Chemistry Analyzer · Class AMFG · 2026-01-30

The Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.

MFG/IVD/2020/000007 · Gujarat
HPLC Analyzer · Class AMFG · 2026-01-30

Analyzer uses ion exchange liquid chromatography for quantitative determination of the content of glycated hemoglobin

MFG/IVD/2020/000007 · Gujarat
Prolactin (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Prolactin (PRL) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrated Sy…

IMP/IVD/2021/000028 · from China
Total ? HCG (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Total ? HCG in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrated System…

IMP/IVD/2021/000028 · from China
AMH (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-Müllerian hormone (AMH) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series …

IMP/IVD/2021/000028 · from China
Vitamin B12 (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Vitamin B12 (Vit B12) in human serum and plasma using the MAGLUMI series Fully auto chemiluminescence immunoassay analyzer and Biolumi series Integra…

IMP/IVD/2021/000028 · from China
TSH (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of thyroid-stimulating hormone (TSH) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi se…

IMP/IVD/2021/000028 · from China
Total T4 (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of total thyroxine (Total T4) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series In…

IMP/IVD/2021/000028 · from China
Total T3 (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of total triiodothyronine (Total T3) in human serum and plasma using the MAGLUMI series Fully-auto Chemiluminescence immunoassay analyzer and Biolumi se…

IMP/IVD/2021/000028 · from China
Testosterone (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Testosterone (TEST) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Integrate…

IMP/IVD/2021/000028 · from China
LH (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of luteinizing hormone (LH) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Inte…

IMP/IVD/2021/000028 · from China
IgE (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of total Immunoglobulin E (IgE) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series …

IMP/IVD/2021/000028 · from China
FSH (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of follicle stimulating hormone (FSH) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi s…

IMP/IVD/2021/000028 · from China
Ferritin (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Ferritin in human serum and plasma using the MAGLUMI series Fullyauto chemiluminescence immunoassay analyzer and Biolumi series Integrated System, an…

IMP/IVD/2021/000028 · from China
cTnl (CLIA) · Class CIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series Int…

IMP/IVD/2021/000028 · from China
25-OH Vitamin D (CLIA) · Class BIMPORT · 2026-01-06

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer and Biolumi series In…

IMP/IVD/2021/000028 · from China
ALKALINE PHOSPHATASE MONO · Class BMFG · 2025-02-11

For the quantitative determination of alkaline phosphatase in human serum or plasma

MFG/IVD/2020/000007 · Gujarat
CK-MB · Class BMFG · 2025-02-11

For the quantitative determination of CK-MB levels in serum or plasma.

MFG/IVD/2020/000007 · Gujarat
LIPASE · Class BMFG · 2025-02-11

For the quantitative determination of Lipase in human serum or plasma.

MFG/IVD/2020/000007 · Gujarat
CREATININE ENZYMATIC · Class BMFG · 2025-02-11

For the quantitative determination of creatinine in human serum or urine.

MFG/IVD/2020/000007 · Gujarat
CREATININE(ALKALINE PICRATE) · Class BMFG · 2025-02-11

For the quantitative determination of creatinine in human serum or urine.

MFG/IVD/2020/000007 · Gujarat
CALCIUM(ARSENAZO- III) · Class BMFG · 2025-02-11

For the quantitative determination of Calcium in serum.

MFG/IVD/2020/000007 · Gujarat
G6PD QUALITATIVE · Class BMFG · 2025-02-11

or the Qualitative determination of G6PDH deficiency in red blood cells.

MFG/IVD/2020/000007 · Gujarat
UREA (UV) · Class BMFG · 2025-02-11

For the quantitative determination of Urea in serum,plasma and urine.

MFG/IVD/2020/000007 · Gujarat
ADENOSINE DEAMINASE · Class BMFG · 2025-02-11

For the quantitative determination of adenosine deaminase(ADA) in human serum,plasma, Pleural fluid,CSF, Pericardial fluid and ascitic fluid.

MFG/IVD/2020/000007 · Gujarat
SODIUM · Class BMFG · 2025-02-11

For the quantitative determination of Sodium in serum.

MFG/IVD/2020/000007 · Gujarat
CHOLESTEROL · Class BMFG · 2025-02-11

For the quantitative determination of cholesterol in human serum or plasma.

MFG/IVD/2020/000007 · Gujarat
ALPHA AMYLASE · Class BMFG · 2025-02-11

For the quantitative determination of alpha-Amylase in human serum ,plasma and urine.

MFG/IVD/2020/000007 · Gujarat
BILIRUBIN TOTAL & DIRECT /J& G · Class BMFG · 2025-02-11

For the quantitative determination of bilirubin TOTAL & DIRECT in human serum.

MFG/IVD/2020/000007 · Gujarat
GLUCOSE · Class BMFG · 2025-02-11

For the quantitative determination of glucose in human serum and plasma (preferably sodium fluoride).

MFG/IVD/2020/000007 · Gujarat
POTASSIUM · Class BMFG · 2025-02-11

For the quantitative determination of Potassium in serum.

MFG/IVD/2020/000007 · Gujarat
ESR TUBE · Class AMFG · 2025-02-11

ESR Tubes are used for the collection and transport of venous blood for blood sedimentation rate testing.

MFG/IVD/2020/000007 · Gujarat
ALKALINE PHOSPHATASE · Class BMFG · 2025-02-11

For the quantitative determination of alkaline phosphatase in human serum or plasma

MFG/IVD/2020/000007 · Gujarat
ALKALINE PHOSPHATASE LYPHO · Class BMFG · 2025-02-11

For the quantitative determination of alkaline phosphatase in human serum or heparin plasma

MFG/IVD/2020/000007 · Gujarat

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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