TROPONIN I TEST DEVICE - India CDSCO Medical Device Registration

TROPONIN I TEST DEVICE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000035_ae1ab441e616685fb0e993f90105ef48_3537fb2d0637f4356baf0ca5a984756c. This device is marketed under the brand name TP. The license holder is Recombigen Laboratories Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class C

TROPONIN I TEST DEVICE

UID: MFG/MD/2018/000035_ae1ab441e616685fb0e993f90105ef48_3537fb2d0637f4356baf0ca5a984756c

Brand Name

License Holder

Recombigen Laboratories Private Limited

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

This is a rapid, in vitro, qualitative lateral flow immunoassay for the detection of cardiac troponin I (TP) in human whole blood/Serum/plasma specimens as an aid in the diagnosis of myocardial infarction