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THERATEST LABORATORIES, INC.

Last updated September 17, 2026

What THERATEST LABORATORIES, INC. makes

TheraTest Laboratories, Inc. manufactures in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits for detecting specific antibodies associated with autoimmune diseases, including multiple systemic lupus erythematosus (SLE)-linked markers like anti-dsDNA, anti-ssDNA, anti-Sm, and anti-SSA/Ro. Their portfolio also includes tests for Sjogren’s syndrome antibodies (SSB/La, SSA/Ro) and scleroderma-related markers such as anti-Scl-70. Additional assays target thyroid-specific antibodies (anti-thyroglobulin, anti-TPO) and anti-centromere antibodies, as well as anti-Jo-1 for connective tissue disorders. The EL-ANA Profiles series provides multi-analyte panels for autoimmune screening.

These diagnostic kits are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway and the Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. in vitro diagnostic device standards. TheraTest Laboratories, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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.

TheraTest Laboratories, Inc. has four recall records on file, all initiated between January 11, 2006, and October 5, 2020, with each record marked as terminated. The reasons cited include validation failures for updated EUA packet requirements (two records), contamination of specimen diluent with fungal growth and missing documentation for a specific kit lot, potential for increased false positives due to cross-reactivity, and instability in the RF IgA Calibrator component of a test system.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.