FDA product code PGX

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Microbiology·Class 2·21 CFR 866.2680
US regulatory classifications
US Product Code (FDA)
PGX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.2680
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

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About this record

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.