FDA-Device2023-04-05Class II
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Randox Laboratories
Hazard
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
Sold states
PA, OH, WV
Affected count
2 kits
Manufactured in
515 Industrial Blvd, N/A, Kearneysville, WV, United States
Products
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2023Don't want to check this manually?
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