Thera Test Laboratories, Inc.
Medical device manufacturer in Lombard, IL.
1510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | 10/09/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2382-2021 Class II | EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128The cross-reactivity of the device may present an increased level of potential false positives. Submitted as… | 10/05/2020Terminated |
| Z-2381-2021 Class II | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately… | 07/30/2020Terminated |
| Z-1546-2012 | RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro…The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a… | 03/29/2012Terminated |