NeuMoDx™ HIV-1 Calibrators - India CDSCO Medical Device Registration

NeuMoDx™ HIV-1 Calibrators is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_2e09571aedf3ecd4b298d280c0f535b0_56ec7506f62552c4542ce422ac5906d4. This device is marketed under the brand name NeuMoDx™ HCV Calibrators. The license holder is QIAGEN India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

NeuMoDx™ HIV-1 Calibrators

UID: IMP/IVD/2022/000261_2e09571aedf3ecd4b298d280c0f535b0_56ec7506f62552c4542ce422ac5906d4

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ HIV-1 Calibrators are a component of the NeuMoDx™ HIV-1 Quant Assay, an in vitro diagnostic nucleic acid amplification test intended for the detection and quantitation of human immunodeficiency virus type 1 (NeuMoDx™ HCV Calibrators) RNA in human plasma