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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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CDSCO Registered
Class Class B
IGFBP-3(IDS-iSYS Insulin-like Growth Factor Binding Protein 3 )
UID: IMP/IVD/2022/000339_dd807036634d9a0d8347aa7939abb3e0_76a211620e1d2c7a5f03637dea4793f2

Brand Name

CTX-I

Device Class

Class B

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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