NeuMoDx™ HIV-1 External Controls - India CDSCO Medical Device Registration

NeuMoDx™ HIV-1 External Controls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_364e36f7b7a1e8378340f0673cb2fc46_1f33ddb8f48c106ac2316bdcdb50ff4a. 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 External Controls

UID: IMP/IVD/2022/000261_364e36f7b7a1e8378340f0673cb2fc46_1f33ddb8f48c106ac2316bdcdb50ff4a

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ HIV-1 External Controls 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