FDA-Device2015-06-10Class III
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
ORTHO-CLINICAL DIAGNOSTICS
Hazard
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Sold states
Nationwide Distribution.
Affected count
Domestic: 898 units
Manufactured in
FELINDRE MEADOWS, N/A, Bridgend, N/A, United Kingdom
Products
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1707-2015Don't want to check this manually?
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