Devices

AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit

Model / Serial
Lot Codes Exp date 04310A-U8 2012-08; 03610A-U8 2012-08 ; 02110A-EU 2011-05 ; 02010A-US 2011-05 ; 00410A-US 2011-05 ; 00110A-US 2010-11 ; 07509A-EU 2010-11 ; 07009A-US 2010-11 ; 06409A-US 2010-11 ; 02909A-EU 2010-02 ; 02309A-US 2010-02;
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.
Product Description
AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia || Catalog Number: KT007
Manufacturer
AdvanDx, Inc.
1 Event
- Recall of AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit

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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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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