NeuMoDx™ 96 Molecular System - India CDSCO Medical Device Registration

NeuMoDx™ 96 Molecular System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000477_596f0453d2c7e0376128037c76f80694_b214c7913d1d9bf36bb669f0a3224bc9. This device is marketed under the brand name NeuMoDx™ 96 Molecular System. The license holder is QIAGEN India Pvt. Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

NeuMoDx™ 96 Molecular System

UID: IMP/IVD/2022/000477_596f0453d2c7e0376128037c76f80694_b214c7913d1d9bf36bb669f0a3224bc9

Brand Name

NeuMoDx™ 96 Molecular System

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The NeuMoDx™ 96 Molecular System is intended for in vitro diagnostic (NeuMoDx™ 96 Molecular System) use in performing NeuMoDx Validated nucleic acid testing in clinical laboratories. The NeuMoDx 96 Molecular System is capable of automated extraction and isolation of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. The system is capable of providing functionality to enable laboratories to develop qualitative and quantitative tests, which use NeuMoDx-provided Consumables and reagents