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

NeuMoDx™ HCV Quant Test Strip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_bd22c2aea5bdf894ffd43a5529f1ec52_4b5832505dda137ca13e376ae1a0300f. 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™ HCV Quant Test Strip

UID: IMP/IVD/2022/000261_bd22c2aea5bdf894ffd43a5529f1ec52_4b5832505dda137ca13e376ae1a0300f

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ HCV Quant Assay is an automated, in vitro nucleic acid amplification test for the quantitation of hepatitis C virus (NeuMoDx™ HCV Calibrators) RNA in human plasma and serum specimens for HCV antibody positive genotypes 1 through 6 of HCV-infected individuals