QIAstat-Dx Gastrointestinal Panel 2 - India CDSCO Medical Device Registration

QIAstat-Dx Gastrointestinal Panel 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000190_9f453e6049ae34495e6c6e6aee03f1c1_5c1022b71aeded95649b09fe29b1e21c. This device is marketed under the brand name QIAstat-Dx Gastrointestinal Panel 2. The license holder is QIAGEN India Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

QIAstat-Dx Gastrointestinal Panel 2

UID: IMP/IVD/2023/000190_9f453e6049ae34495e6c6e6aee03f1c1_5c1022b71aeded95649b09fe29b1e21c

Brand Name

QIAstat-Dx Gastrointestinal Panel 2

License Holder

QIAGEN India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0 and QIAstat-Dx Rise for the simultaneous qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites directly from stool samples in Cary-Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (QIAstat-Dx Gastrointestinal Panel 2), and parasites are identified with the QIAstat-Dx Gastrointestinal Panel 2: Adenovirus F40/F41, Astrovirus, Norovirus (QIAstat-Dx Gastrointestinal Panel 2), Rotavirus A, Sapovirus (QIAstat-Dx Gastrointestinal Panel 2), Campylobacter (QIAstat-Dx Gastrointestinal Panel 2), Clostridium difficile (QIAstat-Dx Gastrointestinal Panel 2), Enteroaggregative Escherichia coli (QIAstat-Dx Gastrointestinal Panel 2), Shigella/Enteroinvasive Escherichia coli (QIAstat-Dx Gastrointestinal Panel 2), Enteropathogenic Escherichia coli (QIAstat-Dx Gastrointestinal Panel 2), Enterotoxigenic Escherichia coli (QIAstat-Dx Gastrointestinal Panel 2) lt/st, Plesiomonas shigelloides, Salmonella spp, Shiga-like toxin-producing Escherichia coli (QIAstat-Dx Gastrointestinal Panel 2) stx1/stx2* (QIAstat-Dx Gastrointestinal Panel 2), Vibrio vulnificus, Vibrio parahaemolyticus, Vibrio cholerae, Yersinia enterocolitica, Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia.