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U.S. Department of Health and Human Services

Product Classification

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Device gbs culture media, selective and differential
Regulation Description Selective culture medium.
Definition Culture medium for gbs detection.
Physical State Media (broth or plates)
Technical Method Chromogenic agar
Target Area not applicable
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePQZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.2360
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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