NeuMoDx™ 288 Molecular System - India CDSCO Medical Device Registration

NeuMoDx™ 288 Molecular System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000477_fa877c9439ad4bc2963b507932b594ef_8793a06925125dfe9e58ba27675861f9. 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™ 288 Molecular System

UID: IMP/IVD/2022/000477_fa877c9439ad4bc2963b507932b594ef_8793a06925125dfe9e58ba27675861f9

Brand Name

NeuMoDx™ 96 Molecular System

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The NeuMoDx™ 288 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 288 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.