Photometric Immunoassay Analyzer - India CDSCO Medical Device Registration

Photometric Immunoassay Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000120_1e382eeb00fb395ea2ffc04d1f9212ed_393406fb29c35d35d75be5499ea78212. This device is marketed under the brand name Swayam, Swandook. The license holder is Mylab Discovery Solutions Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is Pune Division.

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CDSCO Registered

Class Class A

Photometric Immunoassay Analyzer

UID: MFG/IVD/2023/000120_1e382eeb00fb395ea2ffc04d1f9212ed_393406fb29c35d35d75be5499ea78212

Brand Name

Swayam, Swandook

License Holder

Mylab Discovery Solutions Pvt. Ltd.

Device Class

Class A

Approving Authority

Pune Division

Product Information

The instrument is intended to be used for the quantitative and/or qualitative in-vitro determination of chemical and/or biological markers and/or antigen/antibody in the clinical specimen. Photometric Immunoassay Analyzer uses lateral flow chromatographic immunoassay for the qualitative detection of antibodies in a clinical specimen. It is intended to be used as a screening test and provide a preliminary test result to aid in the early diagnosis of any given infection. Any interpretation of this preliminary test result is clinically validated although a professional judgment of a physician is advised before taking any further actions.

Class A

Photometric Immunoassay Analyzer

M/S. MEDSOURCE OZONE BIOMEDICALS PVT LTD

Class A

Brand: PCR

Class A