CDSCO UID IMP/IVD/2019/000352_90c08734eac56a41bd7e8fd447bc3b78_69a07103350ae81bc737fc8b9862f7bb
Anti Phospholipid Screen
Amindo Biologics Pvt. Ltd·Device Class Class B·India CDSCO
Registration details
- UID
- IMP/IVD/2019/000352_90c08734eac56a41bd7e8fd447bc3b78_69a07103350ae81bc737fc8b9862f7bb
- Device class
- Class B
- License holder
- Amindo Biologics Pvt. Ltd
- 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 β2- 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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About this record
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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