6 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148
FDA Recall
Terminated
·Thera Test Laboratories, Inc.·Product code MID·January 11, 2006
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).
FDA Recall
Terminated
·Thera Test Laboratories, Inc.·Product code DHR·March 29, 2012
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
FDA Recall
Terminated
·Thera Test Laboratories, Inc.·Product code QKO·October 5, 2020
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
FDA Recall
Terminated
·Thera Test Laboratories, Inc.·Product code QKO·July 30, 2020
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
FDA Enforcement
Class II
·Terminated·Thera Test Laboratories, Inc.·September 8, 2021
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
FDA Enforcement
Class II
·Terminated·Thera Test Laboratories, Inc.·September 8, 2021