FDA Registration
Active
🇺🇸 United States
THERATEST LABORATORIES, INC.
Reg #: 1421346
·
FEI: 1421346
·
Expires 2026
Products
14
Proprietary Names
30
Establishment Types
1
Classifications
14
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- THERATEST LABORATORIES, INC.
- Registration Number
- 1421346
- FEI Number
- 1421346
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1120 N Du Page Ave
- City
- Lombard
- State
- IL
- ZIP
- 60148
- Country
- US
Regulatory Submissions
- 510(k) Number
- K092757
Owner / Operator
- Firm Name
- TheraTest Labs, Inc.
- Operator Number
- 1421346
- Address
- 1120 N DuPage Ave, --
- City
- Lombard
- State
- IL
- Postal Code
- 60148
- Country
- US
- Correspondent
- Tony - Bowers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | MSV | Class 2 | Immunology | No | 2009-11-18 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2008-02-13 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2008-02-13 |
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2008-02-13 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2007-02-05 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2009-11-18 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2010-12-22 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2008-02-13 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2008-02-13 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2008-02-13 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2008-02-13 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2008-02-13 |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2008-02-13 |
| System, Test, Anticardiolipin Immunological | MID | Class 2 | Immunology | No | 2008-02-13 |
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
EL-aCL IgM, IgG, IgA
EL-aCL screen
EL-Anti-Thyroglobulin
Establishment Types
Manufacture Medical Device