SAA Rapid Quantitative Test - India CDSCO Medical Device Registration
SAA Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000395_9307479e9e0e6e6c12383c21ae5f3d28_04692a5edf75b99ea6c4c0419a400877. This device is marketed under the brand name Biotime . The license holder is M/s Vishat Diagnostic Pvt Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Biotime
License Holder
M/s Vishat Diagnostic Pvt Ltd.Device Class
Approving Authority
CDSCO
Product Information
The SAA Rapid Quantitative Test is intended to quantify the concentration of SAA, in human serum,plasma or whole blood on Biotime FIA Analyzers by fluorescent immunoasay. The test is used as an aid detection of infectious processes, SAA is also used as an aid detection of inflammation
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