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Automated Clinical Chemistry Analyzer EM 360 - India CDSCO Medical Device Registration

Automated Clinical Chemistry Analyzer EM 360 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000114_1418444a041877a499c7157c4b1a8e8f_241874591399db69132fa90f9935ab72. This device is marketed under the brand name Erba. The license holder is Transasia Bio-Medicals Ltd, and it is classified as Device Class Class A. The approving authority is Greater Mumbai Division.

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CDSCO Registered
Class Class A
Automated Clinical Chemistry Analyzer EM 360
UID: MFG/IVD/2022/000114_1418444a041877a499c7157c4b1a8e8f_241874591399db69132fa90f9935ab72

Brand Name

Erba

Device Class

Class A

Approving Authority

Greater Mumbai Division

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 600 tests per hour. The results for tested clinical chemistry parameters can be used for screening, monitoring, 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

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