Automated Clinical Chemistry Analyzer XL 1000 - India CDSCO Medical Device Registration
Automated Clinical Chemistry Analyzer XL 1000 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000101_dc68e0be47cf7be7aff65f54f26e4272_6bb3cc156f35c8adc2bfb7c5ef3b32a1. This device is marketed under the brand name Erba. The license holder is Transasia Bio-Medicals Limited, and it is classified as Device Class Class A. The approving authority is Greater Mumbai Division.
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Brand Name
Erba
License Holder
Transasia Bio-Medicals LimitedDevice Class
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 1040/1145 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
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