Anti Phospholipid Screen - India CDSCO Medical Device Registration
Anti Phospholipid Screen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000352_90c08734eac56a41bd7e8fd447bc3b78_69a07103350ae81bc737fc8b9862f7bb. The license holder is Amindo Biologics Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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License Holder
Amindo Biologics Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
Anti Phospholipid Screen is an indirect solid phase immunoassay kit for the quantitative measurement of IgG and IgM class auto-antibodies directed against ฮฒ2- glycoprotein mediated anionic phospholipids in human serum or plasma, including Cardiolipin, Phosphatidyl serine, Phosphatidyl inositol, Phosphatidic acid, Phosphatidyl choline, Lyso-phosphatidyl choline, Phosphatidyl ethanolamine. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of increased risk of thrombosis in patients with Systemic Lupus Eritematosus ##PLACEHOLDER_0## or similar disorders. Anti Phospholipid Screen kit is intended for laboratory use only
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