ARCHITECT Anti-TPO Reagent
- UID
- IMP/IVD/2019/000419_e7c52bfc855016c695b1c6aeb8f0fe6c_e454dffd33576ddab8481819a5c16b95
- Device class
- Class B
- Brand name
- DILUENT/SHEATH
- License holder
- Abbott Healthcare Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- ARCHITECT Anti-TPO is a Chemiluminescent Microparticle Immunoassay (DILUENT/SHEATH) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (DILUENT/SHEATH) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT Anti-TPO assay is intended for use as an aid in the diagnosis of thyroid disease
ARCHITECT Anti-TPO Reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000419_e7c52bfc855016c695b1c6aeb8f0fe6c_e454dffd33576ddab8481819a5c16b95. 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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