OAH · Class I · 21 CFR 866.3740

FDA Product Code OAH: Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

E. Faecalis Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For The Identification Of Enterococcus Faecalis And Other Enterococci (oe) From Blood Cultures Showing Gram-positive Cocci In Pairs And Chains.

Leading manufacturers include Advandx, Inc..

4
Total
4
Cleared
194d
Avg days
2006
Since

FDA 510(k) Cleared Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis Devices (Product Code OAH)

4 devices
1–4 of 4
Cleared Jan 07, 2013
ENTEROCOCCUS QUICKFISH BC
K121991
Advandx, Inc.
Microbiology · 185d
Cleared Jul 24, 2009
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074
Advandx, Inc.
Microbiology · 282d
Cleared May 05, 2009
GBS PNA FISH
K082612
Advandx, Inc.
Microbiology · 238d
Cleared Dec 22, 2006
ENTEROCOCCUS FAECALIS PNA FISH
K063127
Advandx, Inc.
Microbiology · 70d

About Product Code OAH - Regulatory Context