Access IL-6 - India CDSCO Medical Device Registration

Access IL-6 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000053_ab034330cb6f7a083c71e2639c52e60e_9227424e6615c2cc5a6ceb1eeab4ed08. This device is marketed under the brand name Access Intact PTH. 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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CDSCO Registered

Class Class B

Access IL-6

UID: IMP/IVD/2019/000053_ab034330cb6f7a083c71e2639c52e60e_9227424e6615c2cc5a6ceb1eeab4ed08

Brand Name

Access Intact PTH

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Access IL-6 assay is an in vitro diagnostic test for the quantitative determination of IL-6 levels in human serum and plasma (Access Intact PTH). This assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. The assay may also be used to aid in the study of inflammatory disease. The Access IL-6 assay is a paramagnetic particle, chemiluminescent immunoassay and is intended for use on Access Immunoassay analyzers