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Iron2 - India CDSCO Medical Device Registration

Iron2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000223_efd3d65112e5b91f33d6fee16ebae48a_763e8c795d0cb2376b60981dde0c6c7d. This device is marketed under the brand name ARCHTECT Total T4 Controls. The license holder is Abbott Healthcare 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.

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CDSCO Registered
Class Class B
Iron2
UID: IMP/MD/2018/000223_efd3d65112e5b91f33d6fee16ebae48a_763e8c795d0cb2376b60981dde0c6c7d

Brand Name

ARCHTECT Total T4 Controls

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Iron2 assay is used for the direct colorimetric determination of iron without deproteinization in human serum or plasma on the ARCHITECT c Systems.

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