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ARCHITECT Anti-Tg Calibrators - India CDSCO Medical Device Registration

ARCHITECT Anti-Tg Calibrators is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000419_d5603dbc987d0de2033a22833b556c87_69dedfeb61783e2a45d8f8d428a148d1. This device is marketed under the brand name DILUENT/SHEATH. The license holder is Abbott Healthcare 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
ARCHITECT Anti-Tg Calibrators
UID: IMP/IVD/2019/000419_d5603dbc987d0de2033a22833b556c87_69dedfeb61783e2a45d8f8d428a148d1

Brand Name

DILUENT/SHEATH

Device Class

Class B

Approving Authority

CDSCO

Product Information

The ARCHITECT Anti-Tg Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of the IgG class of thyroglobulin autoantibodies (DILUENT/SHEATH) in human serum and plasma

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