Access TPO Antibody - India CDSCO Medical Device Registration
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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Brand Name
COULTER LH Series Pak Reagent Kit
License Holder
Beckman Coulter India Private LimitedDevice Class
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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