IGFBP-3(IDS-iSYS Insulin-like Growth Factor Binding Protein 3 ) - India CDSCO Medical Device Registration
IGFBP-3(IDS-iSYS Insulin-like Growth Factor Binding Protein 3 ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000339_dd807036634d9a0d8347aa7939abb3e0_76a211620e1d2c7a5f03637dea4793f2. 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 Insulin-like Growth Factor Binding Protein-3 (CTX-I) assay is an in vitro diagnostic device intended for the quantitative determination of IGFBP-3 in human serum or plasma on the IDS systems. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of growth disorders and as an indicator of growth hormone (CTX-I) secretion.
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