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NeuMoDx™ Saliva Collection Kit - India CDSCO Medical Device Registration

NeuMoDx™ Saliva Collection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_7277bc4de038bc2528ab8e3f78ddfd7a_c9291d101096b60867451fc9bd98a5a8. This device is marketed under the brand name NeuMoDx™ LDT Primer/Probe Strip. The license holder is QIAGEN India Pvt. Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered
Class Class A
NeuMoDx™ Saliva Collection Kit
UID: IMP/IVD/2022/000261_7277bc4de038bc2528ab8e3f78ddfd7a_c9291d101096b60867451fc9bd98a5a8

Brand Name

NeuMoDx™ LDT Primer/Probe Strip

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The NeuMoDx™ Saliva Collection Kit is intended for the collection, stabilization, storage, and transport of saliva specimens from individuals suspected of SARS-CoV-2, collected in a clinical setting and to be tested for the detection of SARS-CoV-2 RNA with the NeuMoDx™ SARS-CoV-2 Assay on the NeuMoDx™ Molecular Systems

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