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CDSCO UID IMP/IVD/2022/000152_f7da306f91d97f2178437c33fac4d30b_370f8c417a6ed34b5bb72e44f24c2349

Anti M2-3E ELISA

M/s. CPC Diagnostics Pvt Ltd·Device Class Class B·India CDSCO·Brand: NIL
Registration details
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
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About this record

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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