NeuMoDx™ SARS-CoV-2 Test Strip - India CDSCO Medical Device Registration

NeuMoDx™ SARS-CoV-2 Test Strip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_1c6939bf1f55cd7918d78495208c9c91_8bd2fcefe500d647b930ccf5f06d97bd. 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™ SARS-CoV-2 Test Strip

UID: IMP/IVD/2022/000261_1c6939bf1f55cd7918d78495208c9c91_8bd2fcefe500d647b930ccf5f06d97bd

Brand Name

NeuMoDx™ HCV Calibrators

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NeuMoDx™ SARS-CoV-2 Assay performed on the NeuMoDx 288™ Molecular System and NeuMoDx™ 96 Molecular System (NeuMoDx Molecular System(NeuMoDx™ HCV Calibrators)), is a real-time RT-PCR diagnostic test intended for the qualitative detection of SARS-CoV-2 coronavirus RNA in nasal, nasopharyngeal and oropharyngeal swabs in transport medium, and bronchoalveolar lavage (NeuMoDx™ HCV Calibrators) specimens from individuals suspected of COVID-19 by their healthcare provider.