Devices

Device Recall ImmunoCAP Allergen c6, Amoxicilloyl

Model / Serial
Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). || ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Manufacturer
Phadia US Inc
1 Event
- Recall of Device Recall ImmunoCAP Allergen c6, Amoxicilloyl

Manufacturer

Phadia US Inc

Manufacturer Address
Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
Manufacturer Parent Company (2017)
Fsii Sweden Holdings I Ab
Source
USFDA

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