Quantitative Real-time PCR System(Quantitative Real-time PCR System ) - India CDSCO Medical Device Registration

Quantitative Real-time PCR System(Quantitative Real-time PCR System ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000040_985fad96173b271b0d39a40de384dd56_7bc74cd59c5494e7ea9ba7e66b77635d. This device is marketed under the brand name U2600 Series. The license holder is BIODX HEALTHCARE, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Quantitative Real-time PCR System(Quantitative Real-time PCR System )

UID: IMP/IVD/2020/000040_985fad96173b271b0d39a40de384dd56_7bc74cd59c5494e7ea9ba7e66b77635d

Brand Name

U2600 Series

License Holder

BIODX HEALTHCARE

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Quantitative Real-time PCR System is an automated amplification and detection system for nucleic acid for in vitro diagnostic use. The instrument is intended to perform fluorescence-based PCR to provide quantitative and qualitative detection of nucleic acid sequences in human derived specimens

DJ Fang

MedTech Regulatory Expert

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