Immunology Analyzer/ Semi-automated newborn screening system - India CDSCO Medical Device Registration

Immunology Analyzer/ Semi-automated newborn screening system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000062_df8325cce990103ca069ce1a616d4a0b_89fb341b3f0760d7dbeab31d1c46aac3. This device is marketed under the brand name PCR. The license holder is Mylab Discovery Solutions Pvt. Ltd. Lonavla, and it is classified as Device Class Class A. The approving authority is Pune Division.

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CDSCO Registered

Class Class A

Immunology Analyzer/ Semi-automated newborn screening system

UID: MFG/IVD/2021/000062_df8325cce990103ca069ce1a616d4a0b_89fb341b3f0760d7dbeab31d1c46aac3

Brand Name

PCR

License Holder

Mylab Discovery Solutions Pvt. Ltd. Lonavla

Device Class

Class A

Approving Authority

Pune Division

Product Information

Semi-Automated Newborn Screening System is a fast and accurate system to detect genetic, endocrine, metabolic and various congenital disorders in newborns. The instrument is intended to be used for the quantitative and/or qualitative in-vitro determination of the analytes