FDA-Device2012-10-03Class III
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Sold states
Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
Affected count
810 kits
Manufactured in
2823 Girts Road, N/A, Jamestown, NY, United States
Products
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2445-2012Don't want to check this manually?
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