K-number	K251337
Device name	Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
Applicant	Thermo Fisher Scientific (Oxoid Ltd.)
Product code	JTN
Device class	Class II
Decision date	Dec 5, 2025
Decision	Substantially Equivalent
Regulation	866.1620

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is an antimicrobial susceptibility test disc used in semi-quantitative agar diffusion testing to determine bacterial susceptibility to the antibiotic gepotidacin. It is intended for in vitro diagnostic use to aid clinicians in selecting appropriate antibiotic treatment for patients with suspected microbial infections caused by Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

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