NeuMoDx Lysis Buffer 3 - India CDSCO Medical Device Registration

NeuMoDx Lysis Buffer 3 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_e57318ea6224d39854d6923725261fa3_0fe519c3514e8692aa23cdaaa648a681. 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 Lysis Buffer 3

UID: IMP/IVD/2022/000261_e57318ea6224d39854d6923725261fa3_0fe519c3514e8692aa23cdaaa648a681

Brand Name

NeuMoDx™ LDT Primer/Probe Strip

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

NeuMoDx™ Lysis Buffer 3 is a proprietary buffer used for the efficacious extraction of nucleic acids from unprocessed clinical specimens on the NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (NeuMoDx™ System(NeuMoDx™ LDT Primer/Probe Strip)) when used in conjunction with other NeuMoDx™ reagents such as NeuMoDx™ Extraction Plate, NeuMoDx™ Wash Reagent, and the NeuMoDx™ Release Reagent, which are used for all tests processed on the NeuMoDx Systems. NeuMoDx Lysis Buffer 3 can be used for extraction of viral RNA from human plasma and serum samples

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NeuMoDx™ LDT Primer/Probe Strip

Brand: NeuMoDx™ LDT Primer/Probe Strip

QIAGEN India Pvt. Ltd

NeuMoDx Lysis Buffer 3 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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