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NeuMoDx Lysis Buffer 2 - India CDSCO Medical Device Registration

NeuMoDx Lysis Buffer 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_7691a4748ae172b2ce029f49a58b67fa_3aef07bf88645750ac04e382fe903abf. 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 2
UID: IMP/IVD/2022/000261_7691a4748ae172b2ce029f49a58b67fa_3aef07bf88645750ac04e382fe903abf

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 2 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 2 can be used for extraction of bacterial DNA from human urogenital specimens

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