Devices

Device Recall E.faecalis/OE PNA Fish

Model / Serial
Catalog number KT003
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
Product Description
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 selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media
Manufacturer
AdvanDx, Inc.
1 Event
- Recall of Device Recall E.faecalis/OE PNA Fish

Manufacturer

AdvanDx, Inc.

Manufacturer Address
AdvanDx, Inc., 10a Roessler Rd, Woburn MA 01801-6208
Manufacturer Parent Company (2017)
Advandx, Inc.
Source
USFDA

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