CDSCO UID IMP/IVD/2020/000078_9f8f66b04f3280cc72a8688a3aa3ddf4_5ca9fd8e73596245ab81d5a8ab60c3da
Anti Cardiolipin IgM
M/s Vishat Diagnostic Pvt Ltd.·Device Class Class B·India CDSCO
Registration details
- UID
- IMP/IVD/2020/000078_9f8f66b04f3280cc72a8688a3aa3ddf4_5ca9fd8e73596245ab81d5a8ab60c3da
- 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 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 Systematic Lupus Eritematosus ##PLACEHOLDER_0## or similar disorders
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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/2020/000078_9f8f66b04f3280cc72a8688a3aa3ddf4_5ca9fd8e73596245ab81d5a8ab60c3da. 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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