Anti Cardiolipin IgG - India CDSCO Medical Device Registration
Anti Cardiolipin IgG is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000078_4e8ecaf0f5e20f8dc11e743e3006faec_fa13c66f9feb9a6a81ba7e1b6259aff6. The license holder is M/s Vishat Diagnostic Pvt Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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License Holder
M/s Vishat Diagnostic Pvt Ltd.Device Class
Approving Authority
CDSCO
Product Information
Indirect solid phase immunoassay kit for the quantitative measurement of IgG class auto-antibodies directed against Cardiolipina-ฮฒ2-glycoprotein complex in human serum or plasma. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of increased risk of thrombosis in patients with Systematic Lupus Eritematosus ##PLACEHOLDER_0## or similar disorders
