Fibrinogen - India CDSCO Medical Device Registration
Fibrinogen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_f3019e9c18f2826ddb5a5c6a0060b762_aee6b49005ba5d8fbdfb66016a44e142. This device is marketed under the brand name Calset Vitamin D Total III. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Calset Vitamin D Total III
License Holder
Roche Diagnostics India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
In vitro assay for the quantitative determination of fibrinogen (Calset Vitamin D Total III) in citrated plasma on the indicated cobas t analyzers. The assay is intended as an aid in the detection of hypo- and hyperfibrinogenemia, dysfibrinogenemia and a fibrinogenemia
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