Intact PINP - India CDSCO Medical Device Registration
Intact PINP is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000339_ec38ef40ad8dfab090664d9fb6d69df8_b8d6452575482938c1895c869a0aa0f7. 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
The IDS-iSYS Intact PINP assay (CTX-I) is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS System. The test is intended to be used as an aid in the management of postmenopausal osteoporosis
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