NeuMoDx™ Lysis Buffer 1 - India CDSCO Medical Device Registration

NeuMoDx™ Lysis Buffer 1 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_a7768abc3c63eab2bfd3e3a7447037ab_c9f870fa453c3d368ee3ee22118873d8. 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 1

UID: IMP/IVD/2022/000261_a7768abc3c63eab2bfd3e3a7447037ab_c9f870fa453c3d368ee3ee22118873d8

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 1 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 1 can be used for extraction of viral or bacterial DNA from human plasma and serum specimens.

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NeuMoDx Lysis Buffer 3

Brand: NeuMoDx™ LDT Primer/Probe Strip

QIAGEN India Pvt. Ltd

NeuMoDx™ Lysis Buffer 1 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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