CDSCO UID IMP/IVD/2020/000078_90c08734eac56a41bd7e8fd447bc3b78_7777461a31cc0458f61ddf1c3534d7f1
Anti Phospholipid Screen
M/s Vishat Diagnostic Pvt Ltd.·Device Class Class B·India CDSCO
Registration details
- UID
- IMP/IVD/2020/000078_90c08734eac56a41bd7e8fd447bc3b78_7777461a31cc0458f61ddf1c3534d7f1
- Device class
- Class B
- License holder
- M/s Vishat Diagnostic Pvt Ltd.
- Approving authority
- CDSCO
- Product information
- 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 Systematic Lupus Eritematosus ##PLACEHOLDER_0## or similar disorders
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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/2020/000078_90c08734eac56a41bd7e8fd447bc3b78_7777461a31cc0458f61ddf1c3534d7f1. 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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