NeuMoDx™ HBV Calibrators - India CDSCO Medical Device Registration

NeuMoDx™ HBV Calibrators is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_d93c47fde0b8d43c2531fa676bd9cac7_7ec51cf3ab5a9c70b537f2b1294ac602. 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 Calibrators

UID: IMP/IVD/2022/000261_d93c47fde0b8d43c2531fa676bd9cac7_7ec51cf3ab5a9c70b537f2b1294ac602

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ HBV Calibrators 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 Calibrators are used to establish a calibration coefficient associated with the standard curve of a particular lot of the NeuMoDx™ HBV Quant Test Strip, allowing for the accurate quantitation of HBV DNA in human plasma and serum specimens. The HBV target in these calibrators are traceable to the WHO 4th HBV International Standard

Class C

Brand: careHPV Test Luminometer

Class A