FDA-Device2018-02-14Class II
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
The Binding Site Group, Ltd.
Hazard
The low and high controls for the product are returning results above the assigned values.
Sold states
US Distribution was made to CA. There was no foreign/military/government distribution.
Affected count
49 kits to the U.S. office (32 kits further distributed)
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0553-2018Don't want to check this manually?
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