FDA-Device2020-04-08Class II
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
The Binding Site Group, Ltd.
Hazard
A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
Sold states
U.S.: FL
Affected count
1 kit
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1619-2020Don't want to check this manually?
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