Devices

Device Recall ImmunoCAP" Allergen c5, Ampicilloyl

Model / Serial
Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). || 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 c5, Ampicilloyl

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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