ELISA Plate Analyser - India CDSCO Medical Device Registration

ELISA Plate Analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000047_36b59d95d3f4874e451b06b99a898034_f6b437b12023fe6858fd0289434fd737. This device is marketed under the brand name ALTA. The license holder is ROBONIK (INDIA) PVT.LTD, and it is classified as Device Class Class A. The approving authority is Kokan Division.

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CDSCO Registered

Class Class A

ELISA Plate Analyser

UID: MFG/IVD/2023/000047_36b59d95d3f4874e451b06b99a898034_f6b437b12023fe6858fd0289434fd737

Brand Name

ALTA

License Holder

ROBONIK (INDIA) PVT.LTD

Device Class

Class A

Approving Authority

Kokan Division

Product Information

An ELISA Plate Analyzer (ALTA), intended to be used to scan an immunoassay reagent vehicle after exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen, using photometry. It is intended for in vitro diagnostic use.