Photometric Immunoassay Analyzer
- UID
- MFG/IVD/2023/000120_1e382eeb00fb395ea2ffc04d1f9212ed_393406fb29c35d35d75be5499ea78212
- Device class
- Class A
- Brand name
- Swayam, Swandook
- License holder
- Mylab Discovery Solutions Pvt. Ltd.
- 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.
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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