FDA product code NVQ

Bacteriophage And Controls, B. Anthracis Lysis

Microbiology·Class 2·21 CFR 866.3045
US regulatory classifications
US Product Code (FDA)
NVQ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3045
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.

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About this record

Bacteriophage And Controls, B. Anthracis Lysis 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.