Data / Medical devices / United States / Theratest Laboratories, Inc.

Theratest Laboratories, Inc.: FDA-registered device maker in Lombard, IL, United States, 14 510(k) clearances

Name: Theratest Laboratories, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Theratest Laboratories, Inc. is registered with the FDA (registration 1421346) in Lombard, IL, United States. It lists 14 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 5, 2010. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Theratest Laboratories, Inc.

FDA registration number: 1421346
Address: 1120 N Du Page Ave, Lombard, IL, United States, 60148
Owner or operator: TheraTest Labs, Inc. (1421346)
Roles: Manufacturer
First device listed: February 5, 2007
Registered through: 2026
Brand names listed: EL-ANA Profiles: ANA scr, EL-ANA Profiles: ANA/6, EL-ANA Profiles: ANA/7, EL-ANA Profiles: ANA/8, EL-ANA Profiles: ANA/9, EL-ANA Profiles: anti-Centromere, EL-ANA Profiles: anti-Chromatin, EL-ANA Profiles: anti-Histone and more

Devices it lists

Device	Product code	Class	Role	Source
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	LRM	2	Manufacturer	accessdata.fda.gov
Anti-Ribosomal P Antibodies	MQA	2	Manufacturer	accessdata.fda.gov
Anti-Rnp Antibody, Antigen And Control	LKO	2	Manufacturer	accessdata.fda.gov
Anti-Sm Antibody, Antigen And Control	LKP	2	Manufacturer	accessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	NHX	2	Manufacturer	accessdata.fda.gov
Antibodies, Gliadin	MST	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Endomysial(Tissue Transglutaminase)	MVM	2	Manufacturer	accessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And Control	LLL	2	Manufacturer	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer	accessdata.fda.gov
System, Test, Thyroid Autoantibody	JZO	2	Manufacturer	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Manufacturer	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 5, 2010	K090753	THERATEST EL-ANTI-CCP/2	NHX	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
October 9, 2009	K092757	THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR	MSV	Substantially Equivalent	Thera-Test Laboratories, Inc.	accessdata.fda.gov
September 3, 2009	K090760	THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120	JZO	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
November 5, 2007	K071692	THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS	MVM	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
July 20, 2006	K061376	EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3	MOB	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
February 7, 2006	K060176	EL-ACL SCREEN; EL-ACL IGM, IGG, IGA	MID	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
October 7, 2005	K051066	THERATEST EL-ANA PROFILES	LKP	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
March 11, 2004	K040291	EL-ANA PROFILES: ANTI-CHROMATIN	LJM	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
February 6, 2003	K024151	EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P	MQA	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
February 6, 2003	K024031	THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE	LJM	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
March 6, 1996	K955481	THERATEST KIT (MODIFICATION)	LJM	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
November 14, 1995	K954106	THERATEST LAB, INC., EL-ANASCR KIT	LJM	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
July 28, 1995	K941398	EL-RF/3 (IGM-IGG-IGA) KIT	DHR	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov
January 28, 1994	K933712	EL-RF TEST SYSTEM: EL-RF-IGM KIT	DHR	Substantially Equivalent	Theratest Laboratories, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 5, 2020	88478	Class II	Terminated	EL-Anti-SARS-CoV-2 IgG Kit, Catalog #. Submitted as EUA202128	The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128	accessdata.fda.gov
July 30, 2020	88477	Class II	Terminated	EL-Anti-SARS-CoV-2 IgM Kit, Catalog #, IVD. Submitted as EUA202129	Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129	accessdata.fda.gov
March 29, 2012	61500	Not yet classified	Terminated	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 #. The TheraTest EL-RF/3 is intended as a	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.	accessdata.fda.gov
January 11, 2006	34945	Not yet classified	Terminated	EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148	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 #.	accessdata.fda.gov

Compare with other makers

Updated March 5, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.