Devices

Device Recall Rheumatoid Factor (RF) Kit for use on SPAPLUS

Model / Serial
Lot #416595, Exp. 31/03/2018; UDI #05051700018319
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution was made to CA. There was no foreign/military/government distribution.
Product Description
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A || Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
Manufacturer
The Binding Site Group, Ltd.
1 Event
- Recall of Device Recall Rheumatoid Factor (RF) Kit for use on SPAPLUS

Manufacturer

The Binding Site Group, Ltd.

Manufacturer Address
The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
Manufacturer Parent Company (2017)
Cidron Iugo Sarl
Source
USFDA

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