NXX · Class I · 21 CFR 866.3700

FDA Product Code NXX: Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

The S. Aureus Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For Presumptive Identification Of Staphylococcus Aureus From Blood Cultures With Gram-positive Cocci In Clusters (gpcc). This Device Is Not Exempt Per 21 Cfr Part 866.9(c)(6).

4
Total
4
Cleared
110d
Avg days
2006
Since

FDA 510(k) Cleared Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus Devices (Product Code NXX)

4 devices
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About Product Code NXX - Regulatory Context