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THERATEST LABORATORIES, INC.

Last updated September 17, 2026

Information

Country: US
Address: 1120 N Du Page Ave, Lombard, IL, 60148
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1421346
DUNS Number: —

Catalogue (59)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
EL-ANA Profiles: anti-SSB	104-401	FDA UDI	N/A	Active
EL-ANA Profiles: anti-SSA	104-301	FDA UDI	N/A	Active
EL-Anti-SARS-CoV-2 IgG	104-130	FDA UDI	N/A	Unknown
El-Ana Profiles: Ana/4	105-005	FDA UDI	N/A	Active
EL-ANA Profiles: anti-dsDNA	104-201	FDA UDI	N/A	Active
El-Ana Profiles: Ana/9	104-005	FDA UDI	N/A	Active
EL-anti-Thyroglobulin	104-120	FDA UDI	N/A	Active
El-Ana Profiles: Ana/7	102-005	FDA UDI	N/A	Active
EL-B2GPI IgM, IgG, IgA	401-404	FDA UDI	N/A	Active
EL-anti-TPO	104-119	FDA UDI	N/A	Active
El-Ana Profiles: Ana/6	101-005	FDA UDI	N/A	Active
EL-ANA Profiles: anti-Jo-1	104-901	FDA UDI	N/A	Active
EL-ANA Profiles: anti-Centromere	104-111	FDA UDI	N/A	Active
EL-RF/3 IgM, IgG, IgA	303-305	FDA UDI	N/A	Active
El-Ana Profiles: Ana/8	103-005	FDA UDI	N/A	Active
EL-aCL IgM, IgG, IgA	201-202	FDA UDI	N/A	Active
EL-anti-CCP/2	104-122	FDA UDI	N/A	Active
EL-ANCA: anti-MPO	104-114	FDA UDI	N/A	Active
EL-RF IgM	301-305	FDA UDI	N/A	Active
EL-ANA PROFILES: EL-ANAscr	100-002	FDA UDI	N/A	Active
EL-Anti-SARS-CoV-2 IgM	104-129	FDA UDI	N/A	Unknown
EL-ANA Profiles: anti-ssDNA	104-101	FDA UDI	N/A	Active
EL-ANA Profiles: anti-Scl-70	104-801	FDA UDI	N/A	Active
EL-ANCA: anti-PR3	104-115	FDA UDI	N/A	Active
EL-B2GPI Scr	402-401	FDA UDI	N/A	Active
EL-ANA Profiles: anti-Ribo-P	104-110	FDA UDI	N/A	Active
EL-ANA Profiles: anti-HISTONE	104-701	FDA UDI	N/A	Active
EL-aCL screen	202-202	FDA UDI	N/A	Active
El-Ana Profiles: Ana/4	105-002	FDA UDI	N/A	Active
EL-tTG IgA/IgG	104-117	FDA UDI	N/A	Active
EL-ANA Profiles: anti-Chromatin	104-113	FDA UDI	N/A	Active
EL-Glia IgA/IgG	104-118	FDA UDI	N/A	Active
EL-Anti-SARS-CoV-2	104-128	FDA UDI	N/A	Unknown
EL-ANA PROFILES: EL-ANAscr	100-004	FDA UDI	N/A	Active
EL-ANA Profiles: anti-RNP/Sm	104-601	FDA UDI	N/A	Active
EL-ANA Profiles: anti-Sm	104-501	FDA UDI	N/A	Active
El-Ana Profiles: El-Ena/5	K982622	FDA 510(k)	Class II	Active
Theratest El-Anti-Tpo And Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120	K090760	FDA 510(k)	Class II	Active
El-Rf Test System: El-Rf-Igm Kit	K933712	FDA 510(k)	Class II	Active
The Theratest Aca Test	K905301	FDA 510(k)	Class II	Active
El-Acl Screen; El-Acl Igm, Igg, Iga	K060176	FDA 510(k)	Class II	Active
El-Ana Profiles: El-Ena/4	K982150	FDA 510(k)	Class II	Active
Theratest El-Beta2gpi (igm-Igg-Iga), Theratest El--beta2gpi Scr	K092757	FDA 510(k)	Class II	Active
Theratest Kit (modification)	K955481	FDA 510(k)	Class II	Active
El-Ana Profiles: Anti-Chromatin	K040291	FDA 510(k)	Class II	Active
El-B2gp1scr	K973882	FDA 510(k)	Class II	Active
El-Anca: Anti-Mpo, Anti-Pr3, Anti-Mpo And Anti-Pr3	K061376	FDA 510(k)	Class II	Active
El-Rf/3 (igm-Igg-Iga) Kit	K941398	FDA 510(k)	Class II	Active
The Theratest El-B2gp1 (igm, Igg, Iga) And El-B2gp1scr	K972790	FDA 510(k)	Class II	Active
El-Ana Profiles-2k1	K002559	FDA 510(k)	Class II	Active

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FDA Recalls (4)

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.