Urine BETA CrossLaps® ELISA(Urine BETA CrossLaps® ELISA) - India CDSCO Medical Device Registration
Urine BETA CrossLaps® ELISA(Urine BETA CrossLaps® ELISA) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000339_b93f3a3f4352780eea2f604fe34f33af_277571e1fae9107723ead983121f9fa2. 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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
CTX-I
License Holder
CPC DIAGNOSTICS PVT.LTDDevice Class
Approving Authority
CDSCO
Product Information
The Urine BETA CrossLaps® (CTX-I)ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps® (CTX-I)ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (CTX-I) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (CTX-I) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (CTX-I) with hormones and hormone like drugs b) Bisphosphonate therapies
N-MID Osteocalcin Control
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
25 VitDS Control Set
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
Direct Renin
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
Ostase® BAP EIA
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
IGFBP-3 Control(IDS-iSYS Insulin-like Growth Factor Binding Protein 3 Control Set)
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
Intact PINP
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
Ostase BAP Control Set
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
IGFBP-3(IDS-iSYS Insulin-like Growth Factor Binding Protein 3 )
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
ACTH
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
Intact PINP Control
Brand: CTX-I
CPC DIAGNOSTICS PVT.LTD
Automated Chemistry analyser
Brand: ChemWell 2910
Microplate Washer
Brand: ChemWell 2910
Microplate Reader
Brand: ChemWell 2910
Chemistry analyzer
Brand: ChemWell 2910
Chemistry analyzer
Brand: ChemWell 2910
Microstrip Reader
Brand: ChemWell 2910
IDS-i10 Immunoassay/Biochemistry Analyzer
Brand: IDS-i10
Fluorescent Immunoassay Analyser
Brand: B.R.A.H.M.S KRYPTOR Compact PLUS
Congenital defect/syndrome risk assessment interpretive software
Brand: B.RA.H.M.S Fast Screen pre-I plus