Anti Cardiolipin IgM - India CDSCO Medical Device Registration

Anti Cardiolipin IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000022_9f8f66b04f3280cc72a8688a3aa3ddf4_b4014450c9a8ddfd15fc20c932332326. This device is marketed under the brand name Merilisa. The license holder is Meril Diagnostics Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Gujarat.

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CDSCO Registered

Class Class B

Anti Cardiolipin IgM

UID: MFG/MD/2018/000022_9f8f66b04f3280cc72a8688a3aa3ddf4_b4014450c9a8ddfd15fc20c932332326

Brand Name

Merilisa

License Holder

Meril Diagnostics Pvt. Ltd.

Device Class

Class B

Approving Authority

Gujarat

Product Information

Anti Cardiolipin IgM is an indirect solid phase immunoassay kit for the quantitative measurement of IgM class autoantibodies 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 (Merilisa) or similar disorders. Anti Cardiolipin IgM kit is intended for laboratory use only

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Brand: Merilisa

Meril Diagnostics Pvt. Ltd.

Anti Cardiolipin IgM - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

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