Automated Clinical Chemistry Analyzer EM 200 - India CDSCO Medical Device Registration

Automated Clinical Chemistry Analyzer EM 200 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000074_f9e831c7c0df72a6288df3e5a289603e_1bfbbd1d7e4f5ce47b087cabb77e768a. This device is marketed under the brand name Erba. The license holder is Transasia Diagnostics Private Limited, and it is classified as Device Class Class A. The approving authority is Andhra Pradesh.

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CDSCO Registered

Class Class A

Automated Clinical Chemistry Analyzer EM 200

UID: MFG/IVD/2023/000074_f9e831c7c0df72a6288df3e5a289603e_1bfbbd1d7e4f5ce47b087cabb77e768a

Brand Name

Erba

License Holder

Transasia Diagnostics Private Limited

Device Class

Class A

Approving Authority

Andhra Pradesh

Product Information

Automatic analyzer with additional ISE module intended for in vitro photometric quantification of clinical chemistry parameters and ion-selective quantification of specific electrolytes (Erba) in serum, plasma and urine with capacity 400/500 tests per hour. The results for tested clinical chemistry parameters can be used for screening, monitoring, and diagnosis. The function is specifically dependent on each parameter and is described in IFU of every reagent kit provided by ERBA. For professional use in clinical laboratory only.

Class A

Semi Automated Biochemistry Analyzer

Brand: Erba

Transasia Bio-Medicals Limited

Class A

Brand: Erba Lisa

Class C