Ostase® BAP EIA - India CDSCO Medical Device Registration
Ostase® BAP EIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000339_f35e385eae2f160c8fedbc887828035a_e298e3597937ad96c81ef04a68476a83. This device is marketed under the brand name CTX-I. The license holder is CPC DIAGNOSTICS PVT.LTD, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
CTX-I
License Holder
CPC DIAGNOSTICS PVT.LTDDevice Class
Approving Authority
CDSCO
Product Information
TheOstase® BAPEIAImmunoenzymetricAssayisaninvitrodeviceindicatedforthe quantitative measurement of bone-specific alkaline phosphatase (CTX-I), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the managementofpostmenopausalosteoporosisand Paget’sdisease
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