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Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Sulfisoxazole these include Enterobacteriaceae, and Staphylococcus spp. Sulpfisoxazole Susceptibility Test Discs are only used for testing urine samples.

Oxoid Sulfisoxazole Susceptibility Test Disc

The provided text is a 510(k) premarket notification letter from the FDA to Oxoid, Ltd. regarding their Sulfisoxazole Antimicrobial Susceptibility Test Disc. It confirms the device's substantial equivalence to a legally marketed predicate device. However, the document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or the full 510(k) submission. Therefore, I cannot extract the specific information requested in the prompt.

The document only states the device:

• Trade Name: Sulfisoxazole Antimicrobial Susceptibility Test Disc
• Regulatory Class: II
• Product Code: JTN
• Indication for Use: Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Sulfisoxazole these include Enterobacteriaceae, and Staphylococcus spp. Sulpfisoxazole Susceptibility Test Discs are only used for testing urine samples.

To provide the requested information, the full 510(k) submission document or a clinical study report for this device would be needed.

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