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NeuMoDx™ LDT Primer/Probe Strip - India CDSCO Medical Device Registration

NeuMoDx™ LDT Primer/Probe Strip is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000261_c871dc92cd43d60f84f750a0cb3dc626_16682ea1fe1d9b59c438107ab1ffc318. 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 Primer/Probe Strip
UID: IMP/IVD/2022/000261_c871dc92cd43d60f84f750a0cb3dc626_16682ea1fe1d9b59c438107ab1ffc318

Brand Name

NeuMoDx™ LDT Primer/Probe Strip

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The NeuMoDx LDT Primer/Probe Strip is an empty, 16-well strip used for laboratory-developed tests (NeuMoDx™ LDT Primer/Probe Strip) on the NeuMoDx 288 Molecular System and the NeuMoDx 96 Molecular System (NeuMoDx System(NeuMoDx™ LDT Primer/Probe Strip)). NeuMoDx Systems, in conjunction with NeuMoDx reagents such as NeuMoDx Extraction Plate, NeuMoDx Lysis Buffers, NeuMoDx Wash Reagent and NeuMoDx Release Reagent make the development of LDTs streamlined and efficient, combining sample extraction with real-time PCR in one system. The NeuMoDx LDT Primer/Probe Strip is universally used for all LDTs processed on the NeuMoDx System

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