Weldon Biotech India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 7 |
| Class B | Low–moderate risk | 437 |
| Class C | Moderate–high risk | 45 |
| Class D (high risk) | Highest-risk devices | 2 |
CDSCO device licences
Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis A Virus in human plasma and sera.
IMP/IVD/2020/000842 · from Italy?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 ItalyEnzyme Immunoassay (ELISA) for the determination of IgM antibodies to Hepatitis E Virus in human serum and plasma
IMP/IVD/2020/000842 · from Italy?Capture? Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Hepatitis Delta Virus in human plasma and sera.
IMP/IVD/2020/000842 · from ItalyEnzyme 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 ItalyEnzyme 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 ItalyEnzyme 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 ItalyEnzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Helicobacter pylori in human serum and plasma
IMP/IVD/2020/000842 · from ItalyCompetitive 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 ItalyThird generation Enzyme Immunoassay for the determination of IgG antibodies to Hepatitis E Virus in human serum and plasma
IMP/IVD/2020/000842 · from ItalyThis 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 ItalyEnzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Helicobacter pylori in human serum and plasma
IMP/IVD/2020/000842 · from ItalyThis 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 ItalyWB-C30 3-Part Hematology Analyzer used to count and identify blood cells at high speed with accuracy.
MFG/IVD/2023/000073 · UttarakhandProbe Cleaner WB-C30 is appropriate to series WB-C30 3-Part automated Hematology analyzers, with function of periodic cleaning.
MFG/IVD/2023/000073 · UttarakhandLyse 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 · UttarakhandDiluent 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 · UttarakhandDiazyme 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 StatesDiazyme 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 StatesThe 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 StatesDiazyme 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 StatesThe 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 StatesThe 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 StatesDiazyme 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 StatesDiazyme 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 StatesDiazyme 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 StatesThe 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 StatesThe 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 StatesThe Diazyme Lipase Controls are used to monitor the accuracy and precision of Diazyme?s Lipase Assay (DZ132A)
IMP/IVD/2025/000108 · from United StatesDiazyme 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 StatesThe 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 StatesThe Diazyme Procalcitonin (PCT) Calibrator Set is used for the calibration of the quantitative Diazyme PCT Assay
IMP/IVD/2025/000108 · from United StatesThe 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 StatesThe 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 StatesThe Homocysteine Enzymatic Calibrator is intended for use in the calibration of enzymatic homocysteine assays only
IMP/IVD/2025/000108 · from United StatesDiazyme 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 StatesThe 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 StatesThe 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 StatesThe 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 StatesDiazyme 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 StatesThe Lipase Calibrators is used to establish the value of lipase for Diazyme?s Lipase Assay (DZ132A)
IMP/IVD/2025/000108 · from United StatesDiazyme 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 StatesThe 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 StatesWith the function of cleaning, it has an important effect to clinical diagnosis.
MFG/IVD/2023/000073 · UttarakhandErythroytes lysing agent for white blood cell counting & differential % hemoglobin determination on 5 Diff hematology analyzers.
MFG/IVD/2023/000073 · UttarakhandThis 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 · UttarakhandWith the function of cleaning, it has an important effect to clinical diagnosis.
MFG/IVD/2023/000073 · UttarakhandThis 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 · UttarakhandUse 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 · UttarakhandCN free Lyse Reagent for HB, total WBC and LYM, MID, GRAN Determination. Designed for Serachem SC-60+ Hematology Analyzer.
MFG/IVD/2023/000073 · UttarakhandGlobal 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.