BLOOD-AMMONIA CHECKERS - India CDSCO Medical Device Registration

BLOOD-AMMONIA CHECKERS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000106_a3ea3ea3544e71ba9fd113625c0cc007_e48d0a27d98b3b40d851e4b771fc268c. This device is marketed under the brand name PocketChem UA . The license holder is Arkray Healthcare Pvt., Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

BLOOD-AMMONIA CHECKERS

UID: IMP/IVD/2021/000106_a3ea3ea3544e71ba9fd113625c0cc007_e48d0a27d98b3b40d851e4b771fc268c

Brand Name

PocketChem UA

License Holder

Arkray Healthcare Pvt., Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The PocketChem BA (PocketChem UA ) instrument is intended for the quantitative and automated measurement of ammonia in venous whole blood. This instrument is intended for use with AMMONIA TEST KIT II test strips. Ammonia measurements are used for monitoring and as an aid to diagnosis of liver and kidney disorders in patients diagnosed with or suspected of having these conditions. For in vitro diagnostic use and professional use only. This instrument is not intended for near-patient testing use