ARCHITECT Anti-TPO Reagent - India CDSCO Medical Device Registration
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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Brand Name
DILUENT/SHEATH
License Holder
Abbott Healthcare Pvt. Ltd.Device Class
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
CN-Free HGB/NOC LYSE
Brand: DILUENT/SHEATH
Abbott Healthcare Pvt. Ltd.
WBC Reagent, PART B
Brand: DILUENT/SHEATH
Abbott Healthcare Pvt. Ltd.
Immunoglobulin A
Brand: DILUENT/SHEATH
Abbott Healthcare Pvt. Ltd.
CN-Free Hemoglobin Reagent
Brand: DILUENT/SHEATH
Abbott Healthcare Pvt. Ltd.
HGB/WIC LYSE
Brand: DILUENT/SHEATH
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ARCHITECT Anti-Tg Calibrators
Brand: DILUENT/SHEATH
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WBC Reagent, Part A
Brand: DILUENT/SHEATH
Abbott Healthcare Pvt. Ltd.
ARCHITECT STAT Myoglobin Calibrators
Brand: DILUENT/SHEATH
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Albumin BCP
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Abbott Healthcare Pvt. Ltd.
DILUENT/SHEATH
Brand: DILUENT/SHEATH
Abbott Healthcare Pvt. Ltd.
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Brand: ARCHTECT Total T4 Controls
Iron2
Brand: ARCHTECT Total T4 Controls