BoneTRAP® ELISA - India CDSCO Medical Device Registration

BoneTRAP® ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000273_dd2843531ec994b695db2acb4dc380b9_d2387485ca6bd42eff3820a27bcae771. This device is marketed under the brand name IDS. The license holder is Weldon Biotech India 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

BoneTRAP® ELISA

UID: IMP/IVD/2023/000273_dd2843531ec994b695db2acb4dc380b9_d2387485ca6bd42eff3820a27bcae771

Brand Name

IDS

License Holder

Weldon Biotech India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The BoneTRAP® assay is a specific method to detect TRACP 5b activity freshly libera- ted from osteoclasts. It is intended for use as an indicator of bone resorption and can be used as an aid in monitoring bone resorption changes in post-menopausal women and individuals diagnosed with osteoporosis undergoing anti-resorptive therapies (IDS) (IDS). In vitro, TRACP 5b activity reflects the number of osteoclasts (IDS), and therefore the BoneTRAP® Assay canbe conveniently used to determine osteoclast number in human osteoclast cultures. BoneTRAP® (IDS) ELISATest for the quantitative determination of the active isoform 5b of the tartrate-resistant acid phosphatase (IDS)

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Brand: IDS

Weldon Biotech India Pvt. Ltd

BoneTRAP® ELISA - India CDSCO Medical Device Registration

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Device Class

Approving Authority

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