FDA-Device2018-04-11Class II
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
The Binding Site Group, Ltd.
Hazard
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Sold states
US Distribution was made to CA. There was no foreign/military/government distribution.
Affected count
20 kits distributed to the U.S.
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. 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-1301-2018Don't want to check this manually?
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