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).

Leading manufacturers include Advandx, Inc..

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
1–4 of 4
Cleared Apr 03, 2012
STAPHYLOCOCCUS QUICKFISH BC
K113371
Advandx, Inc.
Microbiology · 139d
Cleared Nov 23, 2009
S. AUREUS/CNS PNA FISH, MODEL KT005
K092166
Advandx, Inc.
Microbiology · 125d
Cleared Aug 18, 2009
S. AUREUS PNA FISH
K091827
Advandx, Inc.
Microbiology · 60d
Cleared May 08, 2006
S. AUREUS PNA FISH
K060099
Advandx, Inc.
Microbiology · 115d

About Product Code NXX - Regulatory Context