Panels › Microbiology › Product code OAH · Class 1
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Regulation 866.3740
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OAH
| Company | 510(k)s | Recalls |
|---|---|---|
| Advandx, Inc. | 4 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2010 | AdvanDx, Inc. E.faecalis/OE PNA FISH
Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and s Terminated |
OAH | K083074 |
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