Vector Biotek Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 74 |
| Class B | Low–moderate risk | 548 |
| Class C | Moderate–high risk | 15 |
| Class D (high risk) | Highest-risk devices | 0 |
CDSCO device licences
A device used to measures the volume of the antigen/antibody present in the components of body fluids.
IMP/IVD/2019/000410 · from ChinaThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · GujaratAnalyzer uses ion exchange high performance liquid chromatography for quantitative determination of the content of glycated hemoglobin.
MFG/IVD/2020/000007 · GujaratThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · Gujarat5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination
MFG/IVD/2020/000007 · GujaratCleaner for Unikon 3 3-part differential blood cell counters
MFG/IVD/2020/000007 · Gujarat5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination
MFG/IVD/2020/000007 · GujaratThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · GujaratThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · GujaratThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · GujaratThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · Gujarat5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination
MFG/IVD/2020/000007 · Gujarat5 part Hematology Analyzer is applies to quantitative analysis of blood cell in clinical examination
MFG/IVD/2020/000007 · GujaratDiluent for Unikon 3 3-part differential blood cell counters
MFG/IVD/2020/000007 · GujaratLyse for Unikon 3 3-part differential blood cell counters
MFG/IVD/2020/000007 · GujaratThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · GujaratThe Auto Chemistry Analyzer is used for quantitative analysis of clinical chemistry components in serum, plasma, urine and cerebrospinal fluid samples.
MFG/IVD/2020/000007 · GujaratAnalyzer uses ion exchange liquid chromatography for quantitative determination of the content of glycated hemoglobin
MFG/IVD/2020/000007 · GujaratThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaThe 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 ChinaFor the quantitative determination of alkaline phosphatase in human serum or plasma
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of CK-MB levels in serum or plasma.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of Lipase in human serum or plasma.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of creatinine in human serum or urine.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of creatinine in human serum or urine.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of Calcium in serum.
MFG/IVD/2020/000007 · Gujarator the Qualitative determination of G6PDH deficiency in red blood cells.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of Urea in serum,plasma and urine.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of adenosine deaminase(ADA) in human serum,plasma, Pleural fluid,CSF, Pericardial fluid and ascitic fluid.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of Sodium in serum.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of cholesterol in human serum or plasma.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of alpha-Amylase in human serum ,plasma and urine.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of bilirubin TOTAL & DIRECT in human serum.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of glucose in human serum and plasma (preferably sodium fluoride).
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of Potassium in serum.
MFG/IVD/2020/000007 · GujaratESR Tubes are used for the collection and transport of venous blood for blood sedimentation rate testing.
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of alkaline phosphatase in human serum or plasma
MFG/IVD/2020/000007 · GujaratFor the quantitative determination of alkaline phosphatase in human serum or heparin plasma
MFG/IVD/2020/000007 · GujaratGlobal 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.