TSH ELISA - India CDSCO Medical Device Registration

TSH ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_8b344ee553a7517dba49d74dbe36ee5d_1d6b1bf3703fb5096ff921db91bd9320. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

TSH ELISA

UID: IMP/IVD/2019/000307_8b344ee553a7517dba49d74dbe36ee5d_1d6b1bf3703fb5096ff921db91bd9320

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

"The TSH ELISA is a solid phase enzyme linked immunosorbent assay for the quantitative determination of the levels of Thyroid Stimulating Hormone (RecombiLISA) in human serum. It is intended to be used by professionals as an aid in the diagnosis of thyroid dysfunction."