THERATEST LABORATORIES, INC.

FDA Device Registration & Listing · Lombard, IL, US · Registration 1421346

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1421346
FEI Number
1421346
Entity Name
THERATEST LABORATORIES, INC.
City/State/Country
Lombard, IL, US
Establishment Address
1120 N Du Page Ave, Lombard, IL 60148, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TheraTest Labs, Inc. (Owner Number: 1421346)
Owner / Operator Contact Address
1120 N DuPage Ave, --, Lombard, IL 60148, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K040291
PMA Number
N/A

All Registered Proprietary Names

EL-B2GPI (IgM, IgG, IgA) EL-B2GPI Scr EL-RF/3 IgM, IgG, IgA EL-ANA Profiles: anti-Centromere EL-ANA Profiles: anti-Ribo P EL-ANA Profiles: anti-Jo-1 EL-ANCA: anti-PR3 EL-ANCA: anti-MPO EL-Anti-TPO EL-Anti-CCP/2 EL-RF IgM EL-ANA Profiles: ANA scr EL-ANA Profiles: anti-SSA EL-ANA Profiles: anti-dsDNA EL-ANA Profiles: anti-Histone EL-ANA Profiles: anti-Sm EL-ANA Profiles: anti-RNP/Sm EL-ANA Profiles: anti-ssDNA EL-ANA Profiles: ANA/8 EL-ANA Profiles: ANA/6 EL-ANA Profiles: anti-SSB EL-ANA Profiles: ANA/9 EL-ANA Profiles: anti-Scl-70 EL-ANA Profiles: ANA/7 EL-tTG IgA/IgG EL-Glia IgA/IgG EL-ANA Profiles: anti-Chromatin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2009-11-18
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2008-02-13
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2008-02-13
MQA Anti-Ribosomal P Antibodies Immunology Class 2 866.5100 2008-02-13
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2008-02-13
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2007-02-05
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2009-11-18
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2010-12-22
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2008-02-13
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2008-02-13
LKP Anti-Sm Antibody, Antigen And Control Immunology Class 2 866.5100 2008-02-13
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2008-02-13
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2008-02-13
MQA Anti-Ribosomal P Antibodies Immunology Class 2 866.5100 2008-02-13
LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control Immunology Class 2 866.5100 2008-02-13
LKO Anti-Rnp Antibody, Antigen And Control Immunology Class 2 866.5100 2008-02-13
MST Antibodies, Gliadin Immunology Class 2 866.5750 2008-02-13
MVM Autoantibodies, Endomysial(Tissue Transglutaminase) Immunology Class 2 866.5660 2008-02-13
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2008-02-13

Official Correspondent

Tony Bowers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TheraTest Labs, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K091556 Instrumentation Laboratory CO HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS 2010-05-21
K000362 Zeus Scientific, Inc. MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM 2000-02-18
K250250 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Anti-Thyroid Peroxidase II 2025-10-17
K152061 Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material 2016-03-03
K000755 Rhigene, Inc. RHIGENE MESACUP2 TEST- SM 2000-05-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2013 Beckman Coulter Inc. 2
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0003-2007 N/A 2
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1421346. Last updated year: 2026. Please use registration number 1421346 when referencing this establishment in official correspondence.
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