NeuMoDx™ HBV External Controls - India CDSCO Medical Device Registration

NeuMoDx™ HBV External Controls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_21dd36b3453d6f76c735e6f4f0112bf7_42a8a0cc98f775cea3605c2d76ca6391. 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™ HBV External Controls

UID: IMP/IVD/2022/000261_21dd36b3453d6f76c735e6f4f0112bf7_42a8a0cc98f775cea3605c2d76ca6391

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ HBV External Controls are a component of the NeuMoDx™ HBV Quant Assay, an in vitro diagnostic nucleic acid amplification test intended for the detection and quantitation of hepatitis B virus (NeuMoDx™ HCV Calibrators) DNA in human plasma and serum. As implemented on the fully automated NeuMoDx™ 288 Molecular System or NeuMoDx™ 96 Molecular System (NeuMoDx™ System(NeuMoDx™ HCV Calibrators)), the NeuMoDx HBV External Controls are used to establish runtime validity required to execute the NeuMoDx HBV Quant Assay for accurate quantitation of HBV DNA in human plasma and serum specimens

Class C

Brand: careHPV Test Luminometer

Class A