CDSCO UID IMP/IVD/2019/000352_9f8f66b04f3280cc72a8688a3aa3ddf4_de4b07e4dfb46d2b8b848d7693eea2cb
Anti Cardiolipin IgM
Amindo Biologics Pvt. Ltd·Device Class Class B·India CDSCO
Registration details
- UID
- IMP/IVD/2019/000352_9f8f66b04f3280cc72a8688a3aa3ddf4_de4b07e4dfb46d2b8b848d7693eea2cb
- Device class
- Class B
- License holder
- Amindo Biologics Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- Anti Cardiolipin IgM kit is an indirect solid phase immunoassay kit for the quantitative measurement of IgM class auto-antibodies directed against Cardiolipina-β2- 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 Systemic Lupus Eritematosus ##PLACEHOLDER_0## or similar disorders. Anti Cardiolipin IgM kit is intended for laboratory use only
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About this record
Anti Cardiolipin IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000352_9f8f66b04f3280cc72a8688a3aa3ddf4_de4b07e4dfb46d2b8b848d7693eea2cb. 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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