3 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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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.
FDA Enforcement
Class III
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·October 3, 2012
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
FDA Enforcement
Class III
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·September 21, 2016
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
FDA Enforcement
Class III
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·December 24, 2014