NeuMoDx™ HBV Quant Test Strip - India CDSCO Medical Device Registration

NeuMoDx™ HBV Quant Test Strip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_1a99df3b0f467c9922bf94a414c25964_c625f459bc3dfc8946c8109a3347115c. 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 Quant Test Strip

UID: IMP/IVD/2022/000261_1a99df3b0f467c9922bf94a414c25964_c625f459bc3dfc8946c8109a3347115c

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ HBV Quant Assay is an automated, in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (NeuMoDx™ HCV Calibrators) DNA in human plasma and serum specimens for HBV genotypes A through H of HBV-infected individuals. The NeuMoDx HBV Quant Assay implemented on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (NeuMoDx™ System(NeuMoDx™ HCV Calibrators)) incorporates automated DNA extraction to isolate target nucleic acid from the specimen and real-time polymerase chain reaction (NeuMoDx™ HCV Calibrators) to target the highly conserved sequences in the Hepatitis B viral genome

Class C

Brand: careHPV Test Luminometer

Class A