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THERATEST LABORATORIES, INC.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Theratest Lab, Inc., El-Anascr Kit	K954106	FDA 510(k)	Class II	Active
The Theratest El-Ana Profiles	K914454	FDA 510(k)	Class II	Active
El-Ana Profiles: Anti-Ribosomal Protein P	K024151	FDA 510(k)	Class II	Active
Theratest El-Ana Profiles	K051066	FDA 510(k)	Class II	Active
Theratest El-Rfscr	K962050	FDA 510(k)	Class II	Active
Theratest El-Ttg Iga/Igg And Theratest El-Glia Iga/Igg Test Systems	K071692	FDA 510(k)	Class II	Active
Theratest El-Anti-Ccp/2	K090753	FDA 510(k)	Class II	Active
The Theratest El-Ana Profiles: Anti-Centromere	K024031	FDA 510(k)	Class II	Active
Theratest El-Ana Profiles Test System	K950716	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 5, 2020	Z-2382-2021	—	terminated	The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Jul 30, 2020	Z-2381-2021	—	terminated	Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Mar 29, 2012	Z-1546-2012	—	terminated	The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a drop in the RF IgA calibrator OD value which could invalidate an RF IgA test run.
Jan 11, 2006	Z-0835-06	—	terminated	The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.