Importer / authorised agent · Uttarakhand · India

Weldon Biotech India Pvt. Ltd.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
491
Manufacturing
133
Import
358
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices7
Class BLow–moderate risk437
Class CModerate–high risk45
Class D (high risk)Highest-risk devices2

CDSCO device licences

HAV Ab · Class BIMPORT · 2026-01-01

Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis A Virus in human plasma and sera.

IMP/IVD/2020/000842 · from Italy
HAV IgM · Class BIMPORT · 2026-01-01

?Capture? Enzyme ImmunoAssay (ELISA) for the determination of IgM class antibodies to Hepatitis A Virus in human plasma and sera

IMP/IVD/2020/000842 · from Italy
HEV IgM · Class BIMPORT · 2026-01-01

Enzyme Immunoassay (ELISA) for the determination of IgM antibodies to Hepatitis E Virus in human serum and plasma

IMP/IVD/2020/000842 · from Italy
HDV IgM · Class BIMPORT · 2026-01-01

?Capture? Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Hepatitis Delta Virus in human plasma and sera.

IMP/IVD/2020/000842 · from Italy
HBc IgM · Class CIMPORT · 2025-11-20

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgM class antibodies to Hepatitis B Virus core Antigen in human plasma and sera with the "capture" system. The kit is intended for the classification of the viral …

IMP/IVD/2020/000842 · from Italy
HBsAb · Class DIMPORT · 2025-11-20

Enzyme ImmunoAssay (ELISA) for both the quantitative and qualitative determination of antibodies to the Surface Antigen of Hepatitis B Virus in human plasma and sera.

IMP/IVD/2020/000842 · from Italy
HBeAg&Ab · Class CIMPORT · 2025-11-12

Enzyme ImmunoAssay (ELISA) for the determination of Hepatitis B Virus "e" Antigen and Antibody in human plasma and sera. The kit is intended for the follow-up of acute infection and of chronicpatients under therapy.

IMP/IVD/2020/000842 · from Italy
HP IgM · Class BIMPORT · 2025-11-12

Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Helicobacter pylori in human serum and plasma

IMP/IVD/2020/000842 · from Italy
HBc Ab · Class CIMPORT · 2025-11-12

Competitive Enzyme ImmunoAssay (ELISA) for thedetermination of antibodies to Hepatitis B core Antigen in human plasma and sera. The kit may be used for the screening of blood units and the follow-up of HBV-infected patients. For ?in vitro? …

IMP/IVD/2020/000842 · from Italy
HEV IgG · Class BIMPORT · 2025-11-12

Third generation Enzyme Immunoassay for the determination of IgG antibodies to Hepatitis E Virus in human serum and plasma

IMP/IVD/2020/000842 · from Italy
HP IgA · Class BIMPORT · 2025-11-12

This device HPA.CE is a quantitative/qualitative test to determinate IgA antibodies to Helicobacter pylori in human plasma and sera. The HPA.CE test can be used manually or automatically. The HPA.CE test is intended exclusively for in vitro…

IMP/IVD/2020/000842 · from Italy
HP IgG · Class BIMPORT · 2025-11-12

Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Helicobacter pylori in human serum and plasma

IMP/IVD/2020/000842 · from Italy
HP Ag · Class BIMPORT · 2025-11-12

This device HP Ag is a quantitative/qualitative test to determination of Helicobacter pylori in human stool. The HPAG.CE test is intended exclusively for in vitro diagnostic use.

IMP/IVD/2020/000842 · from Italy
3-Part Hematology Analyzer · Class AMFG · 2025-09-12

WB-C30 3-Part Hematology Analyzer used to count and identify blood cells at high speed with accuracy.

MFG/IVD/2023/000073 · Uttarakhand
Probe Cleaner · Class BMFG · 2025-09-12

Probe Cleaner WB-C30 is appropriate to series WB-C30 3-Part automated Hematology analyzers, with function of periodic cleaning.

MFG/IVD/2023/000073 · Uttarakhand
Lyse · Class BMFG · 2025-09-12

Lyse WB-C30 is appropriate to series WB-C30 3-Part automated Hematology analyzers, with function of measuring the blood cell content.

MFG/IVD/2023/000073 · Uttarakhand
Diluent · Class BMFG · 2025-09-12

Diluent WB-C30 is appropriate to series WB-C30 3-Part automated Hematology analyzers, with function of measuring the blood cell content.

MFG/IVD/2023/000073 · Uttarakhand
Procalcitonin (PCT) Assay · Class BIMPORT · 2025-09-02

Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method intended for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma.

IMP/IVD/2025/000108 · from United States
Total Bile Acids Calibrator · Class BIMPORT · 2025-09-02

Diazyme Total Bile Acid Calibrator is intended to be used for calibration of Diazyme Total Bile Acid Assay. The calibrator is used in the calculation of Total Bile Acid (TBA) concentrations in unknown serum and plasma samples

IMP/IVD/2025/000108 · from United States
Cystatin C Assay · Class BIMPORT · 2025-09-02

The Diazyme Cystatin C Assay Kit and the Diazyme Cystatin C Calibrator Set are intended for the in vitro quantitative determination of Cystatin C in serum or plasma.

IMP/IVD/2025/000108 · from United States
Total Bile Acids Assay · Class BIMPORT · 2025-09-02

Diazyme Total Bile Acids Assay Kit is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum samples

IMP/IVD/2025/000108 · from United States
Total Bile Acids Control Set · Class BIMPORT · 2025-09-02

The Diazyme Total Bile Acid Control Set is intended for use as quantitative quality controls for the Diazyme Total Bile Acid Assay

IMP/IVD/2025/000108 · from United States
Lp-PLA2 Activity Test Controls · Class BIMPORT · 2025-09-02

The Diazyme Lp-PLA2 Activity Test Controls are intended for use as a quality control tool to monitor the performance within the clinical range of the Diazyme PLAC® Test for Lp-PLA2 Activity, an enzyme assay for the quantitative determinatio…

IMP/IVD/2025/000108 · from United States
Direct Enzymatic HbA1c Assay . · Class BIMPORT · 2025-09-02

Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbA1c) reagents are intended for use in the quantitative determination of stable HbA1c in human whole blood samples.

IMP/IVD/2025/000108 · from United States
1,5 Anhydroglucitol (1,5-AG) Assay · Class BIMPORT · 2025-09-02

Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5- AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitorin…

IMP/IVD/2025/000108 · from United States
Carbon Dioxide Enzymatic Assay · Class BIMPORT · 2025-09-02

Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO2 ) in serum and plasma

IMP/IVD/2025/000108 · from United States
Lp-PLA2 Activity Test Calibrators · Class BIMPORT · 2025-09-02

The Diazyme Lp-PLA2 Activity Test Calibrators are intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 activity by the Diazyme PLAC® Test for Lp-PLA2 Activity

IMP/IVD/2025/000108 · from United States
PLAC® Test for Lp-PLA2 Activity · Class BIMPORT · 2025-09-02

The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoproteinassociated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers

IMP/IVD/2025/000108 · from United States
Lipase Controls · Class BIMPORT · 2025-09-02

The Diazyme Lipase Controls are used to monitor the accuracy and precision of Diazyme?s Lipase Assay (DZ132A)

IMP/IVD/2025/000108 · from United States
Lipase Assay · Class BIMPORT · 2025-09-02

Diazyme Lipase assay in conjunction with lipase assay calibrator set is intended for the in vitro quantitative determination of lipase in serum or plasma.

IMP/IVD/2025/000108 · from United States
Lipoprotein (a) Assay · Class BIMPORT · 2025-09-02

The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Lipoprotein(a) [Lp(a)] concentration in human serum or plasma on Clinical Chemistry Systems …

IMP/IVD/2025/000108 · from United States
Procalcitonin Calibrator Set · Class BIMPORT · 2025-09-02

The Diazyme Procalcitonin (PCT) Calibrator Set is used for the calibration of the quantitative Diazyme PCT Assay

IMP/IVD/2025/000108 · from United States
Homocysteine 2 Reagent Enzymatic Assay · Class BIMPORT · 2025-09-02

The Diazyme Homocysteine 2 Reagent Enzymatic Assay is intended for the in vitro quantitative determination of total Lhomocysteine in serum or plasma. The assay can assist in diagnosis and treatment of patients suspected of having hyperhomoc…

IMP/IVD/2025/000108 · from United States
HDL-Cholesterol Assay · Class BIMPORT · 2025-09-02

The Diazyme HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for deve…

IMP/IVD/2025/000108 · from United States
Homocysteine Enzymatic Assay 5 Point Calibrator Set · Class BIMPORT · 2025-09-02

The Homocysteine Enzymatic Calibrator is intended for use in the calibration of enzymatic homocysteine assays only

IMP/IVD/2025/000108 · from United States
Glycated Serum Protein Assay · Class BIMPORT · 2025-09-02

Diazyme Glycated Serum Protein Assay in conjunction with Diazyme Glycated Serum Protein single calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum

IMP/IVD/2025/000108 · from United States
HDL-LDL Cholesterol Calibrator · Class BIMPORT · 2025-09-02

The HDL-LDL calibrator is used to establish the value of high density lipoprotein cholesterol and low-density lipoprotein cholesterol for Diazyme?s HDL Cholesterol Enzymatic and LDL Cholesterol Enzymatic Assays, respectively

IMP/IVD/2025/000108 · from United States
D-Dimer Assay · Class BIMPORT · 2025-09-02

The D-Dimer Assay is for the quantitative determination of fibrinogen/fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis

IMP/IVD/2025/000108 · from United States
LDL-Cholesterol Assay . · Class BIMPORT · 2025-09-02

The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of develop…

IMP/IVD/2025/000108 · from United States
Glycated Serum Protein Calibrator Set · Class BIMPORT · 2025-09-02

Diazyme Glycated Serum Protein (GSP) Calibrator Kit is intended to be used for calibration of Diazyme Glycated Serum Protein Assay

IMP/IVD/2025/000108 · from United States
Lipase Calibrator · Class BIMPORT · 2025-09-02

The Lipase Calibrators is used to establish the value of lipase for Diazyme?s Lipase Assay (DZ132A)

IMP/IVD/2025/000108 · from United States
Homocysteine Enzymatic Assay Control Set · Class BIMPORT · 2025-09-02

Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Ass…

IMP/IVD/2025/000108 · from United States
Procalcitonin Control Set · Class BIMPORT · 2025-09-02

The Diazyme Procalcitonin (PCT) Control Set is used for the quality control procedures in examining the accuracy and precision of the quantitative Diazyme PCT Assay

IMP/IVD/2025/000108 · from United States
Rinse · Class BMFG · 2025-07-29

With the function of cleaning, it has an important effect to clinical diagnosis.

MFG/IVD/2023/000073 · Uttarakhand
Lyse · Class BMFG · 2025-07-29

Erythroytes lysing agent for white blood cell counting & differential % hemoglobin determination on 5 Diff hematology analyzers.

MFG/IVD/2023/000073 · Uttarakhand
Diluent · Class BMFG · 2025-07-29

This product is used on 3 Part-Diff Auto Hematology Analyzer along with Lyse for testing the cell content in human blood.

MFG/IVD/2023/000073 · Uttarakhand
Rinse · Class BMFG · 2025-07-29

With the function of cleaning, it has an important effect to clinical diagnosis.

MFG/IVD/2023/000073 · Uttarakhand
Diluent · Class BMFG · 2025-07-29

This product is used on 3 Part-Diff Auto Hematology Analyzer along with Lyse for testing the cell content in human blood.

MFG/IVD/2023/000073 · Uttarakhand
Rinse · Class BMFG · 2025-07-29

Use together with matched serial hematology analyzers, providing the stable condition for human blood cell counting and determination of blood cell volume and HGB.

MFG/IVD/2023/000073 · Uttarakhand
Lyse · Class BMFG · 2025-07-29

CN free Lyse Reagent for HB, total WBC and LYM, MID, GRAN Determination. Designed for Serachem SC-60+ Hematology Analyzer.

MFG/IVD/2023/000073 · Uttarakhand

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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