NephroCheck Test Controls - India CDSCO Medical Device Registration
NephroCheck Test Controls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000135_dcc0d0c80af02845b58640e221d6ca82_d9c0230c17c3174bc8ebc6e1f3430eef. This device is marketed under the brand name VITROS Immunodiagnostic Products Total T4 Reagent Pack. The license holder is M/s. Ortho Clinical Diagnostics India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
VITROS Immunodiagnostic Products Total T4 Reagent Pack
License Holder
M/s. Ortho Clinical Diagnostics India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
For in vitro diagnostic use only. For use in monitoring the performance of the Immunodiagnostic System and the Integrated Systems with the VITROS NEPHROCHECK Test (VITROS Immunodiagnostic Products Total T4 Reagent Pack)
Intact PTH Controls
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
Anti-HAV Total Controls
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
FSH Calibrators
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
Intact PTH Assay
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
Progesterone Assay
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
Ferritin Assay
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
B12 Assay
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
B12 Calibrators
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
Anti-HAV IgM Assay
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
NephroCheck Test Calibrator
Brand: VITROS Immunodiagnostic Products Total T4 Reagent Pack
M/s. Ortho Clinical Diagnostics India Private Limited
VITROS Chemistry Products UD20 Packs (VITROS Chemistry Products UD20 Packs )
Brand: BSA/Saline
Reference Fluid
Brand: Transferrin, C3, C4, IgA, IgG, IgM
Reference Fluid
Brand: Transferrin, C3, C4, IgA, IgG, IgM
Direct Total Iron Binding Capacity Reagent
Brand: Transferrin, C3, C4, IgA, IgG, IgM
Prealbumin Calibrator
Brand: Transferrin, C3, C4, IgA, IgG, IgM
VITROS Chemistry Products UD03 Packs (VITROS Chemistry Products UD03 Packs )
Brand: BSA/Saline
Barbiturates Reagent
Brand: VITROS Chemistry Products AMPH Reagent
Apolipoprotein B Calibrator
Brand: Transferrin, C3, C4, IgA, IgG, IgM
Diluent(VITROS Chemistry Products FS Diluent Pack 2 )
Brand: BSA/Saline
Urine Protein Control Level II
Brand: Transferrin, C3, C4, IgA, IgG, IgM