Automated Clinical Chemistry Analyzer EM 200
- UID
- MFG/IVD/2023/000074_f9e831c7c0df72a6288df3e5a289603e_1bfbbd1d7e4f5ce47b087cabb77e768a
- Device class
- Class A
- Brand name
- Erba
- License holder
- Transasia Diagnostics Private Limited
- 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.
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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