NeuMoDx™ HIV-1 Quant Test Strip - India CDSCO Medical Device Registration

NeuMoDx™ HIV-1 Quant Test Strip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_58a6cc578b8866c98847ecfbc30c0182_a79f45be604e9f0287e2d24f1de50779. 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 Quant Test Strip

UID: IMP/IVD/2022/000261_58a6cc578b8866c98847ecfbc30c0182_a79f45be604e9f0287e2d24f1de50779

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ HIV-1 Quant Assay, performed on the NeuMoDx™ 96 Molecular System and NeuMoDx™ 288 Molecular System (NeuMoDx™ System(NeuMoDx™ HCV Calibrators)), is an automated, quantitative and qualitative in vitro diagnostic nucleic acid amplification test designed for quantitation and detection of human immunodeficiency virus type 1 (NeuMoDx™ HCV Calibrators) RNA in human plasma