CDSCO UID IMP/IVD/2019/000040_c9ef8ac37de06ece1fe3f924e6ffc134_addb17caf47ac919e2b08f3161ec30dd
Access TPO Antibody
Beckman Coulter India Private Limited·Device Class Class B·India CDSCO·Brand: COULTER LH Series Pak Reagent Kit
Registration details
- UID
- IMP/IVD/2019/000040_c9ef8ac37de06ece1fe3f924e6ffc134_addb17caf47ac919e2b08f3161ec30dd
- Device class
- Class B
- Brand name
- COULTER LH Series Pak Reagent Kit
- License holder
- Beckman Coulter India Private Limited
- Approving authority
- CDSCO
- Product information
- The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (COULTER LH Series Pak Reagent Kit) levels in human serum and plasma using the Access Immunoassay Systems.
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About this record
Access TPO Antibody is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_c9ef8ac37de06ece1fe3f924e6ffc134_addb17caf47ac919e2b08f3161ec30dd. This device is marketed under the brand name COULTER LH Series Pak Reagent Kit. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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