ANA Screen - India CDSCO Medical Device Registration

ANA Screen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000308_c09a203e1534684d2cc369e0de3d2d51_418e82844d92246982698b29408768a6. This device is marketed under the brand name --. The license holder is Meril Diagnostics Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

ANA Screen

UID: IMP/IVD/2019/000308_c09a203e1534684d2cc369e0de3d2d51_418e82844d92246982698b29408768a6

Brand Name

License Holder

Meril Diagnostics Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

ANA Screen kit is an indirect solid phase enzyme immunometric assay (--) designed for semiquantitative measurement of IgG antibodies directed against Sm (--), RNP/Sm, Scl-70, SS-A (--) (--), SS-B (--), Jo1, U1-SmRNP, CENP-B, dsDNA, and Histones in human serum or plasma