CDSCO UID IMP/IVD/2022/000152_f7da306f91d97f2178437c33fac4d30b_370f8c417a6ed34b5bb72e44f24c2349Anti M2-3E ELISA
- UID
- IMP/IVD/2022/000152_f7da306f91d97f2178437c33fac4d30b_370f8c417a6ed34b5bb72e44f24c2349
- Device class
- Class B
- Brand name
- NIL
- License holder
- M/s. CPC Diagnostics Pvt Ltd
- Approving authority
- CDSCO
- Product information
- The ELISA test kit provides a semiquantitative or quantitative in vitro assay for human antibodies of the immunoglobulin class IgG against the mitochondrial antigens M2 in serum or plasma to support the diagnosis of primary biliary cirrhosis (NIL) and overlap syndrome with autoimmune hepatitis
Anti M2-3E ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000152_f7da306f91d97f2178437c33fac4d30b_370f8c417a6ed34b5bb72e44f24c2349. This device is marketed under the brand name NIL. The license holder is M/s. CPC Diagnostics Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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