QIAstat-Dx Analyzer 1.0 - India CDSCO Medical Device Registration
QIAstat-Dx Analyzer 1.0 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000361_ee8129a9475474af527ab1a6d6d21fc1_db9e870c5558523ba5661e793f5031fb. This device is marketed under the brand name QIAstat-Dx. 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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Brand Name
QIAstat-Dx
License Holder
QIAGEN India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
The QIAstat-Dx Analyzer 1.0 is intended for in vitro diagnostic use and provides diagnostic results. All analytical steps are fully automated using molecular diagnostic QIAstat-Dx cartridges and real-time PCR detection. The QIAstat-Dx Analyzer 1.0 system is intended for professional use only and is not intended for self-testing.
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