NeuMoDx™ LDT Master Mix, DNA - India CDSCO Medical Device Registration

NeuMoDx™ LDT Master Mix, DNA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_b2ae98734ac2d8b5350753fcbf483229_3d57aaaebe443ff121802af70be562cd. 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™ LDT Master Mix, DNA

UID: IMP/IVD/2022/000261_b2ae98734ac2d8b5350753fcbf483229_3d57aaaebe443ff121802af70be562cd

Brand Name

NeuMoDx™ LDT Primer/Probe Strip

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

NeuMoDx LDT Master Mix, DNA is a 16-well strip containing a proprietary, room-temperature stable, real-time PCR master mix that, when used in conjunction with assay specific primers and probe(NeuMoDx™ LDT Primer/Probe Strip), enables a laboratory to rapidly develop and implement laboratory developed tests (NeuMoDx™ LDT Primer/Probe Strip) on the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System(NeuMoDx™ LDT Primer/Probe Strip)). Other than the LDT-specific primers and probe(NeuMoDx™ LDT Primer/Probe Strip), the NeuMoDx™ LDT Master Mix, DNA incorporates all the reagents required for real-time PCR. Once validated by the user’s laboratory as part of the LDT, this reagent can be used as a key component for rapid automation of the LDT

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NeuMoDx Lysis Buffer 3

Brand: NeuMoDx™ LDT Primer/Probe Strip

QIAGEN India Pvt. Ltd

NeuMoDx™ LDT Master Mix, DNA - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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