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Sign in to claim this brandCLARK LABORATORIES, INC.
US
Last updated May 24, 2026
What CLARK LABORATORIES, INC. makes
Clark Laboratories, Inc. manufactures in vitro diagnostic (IVD) kits and reagents for enzyme immunoassays (EIA), including tests for Treponema pallidum, Epstein-Barr virus (EBV) IgG and IgM antibodies, and Borrelia burgdorferi IgG/IgM antibodies. The company also supplies buffered sample diluents, wash solutions, viral transport media, and antimicrobial supplements for laboratory use.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Clark Laboratories, Inc. manufacture?
Clark Laboratories, Inc. specializes in in vitro diagnostic (IVD) devices, primarily enzyme immunoassay (EIA) kits and reagents. These include tests for detecting antibodies to Treponema pallidum (syphilis), Epstein-Barr virus (EBV) IgG and IgM antibodies, and Borrelia burgdorferi (Lyme disease) IgG/IgM antibodies. The company also produces supporting laboratory reagents like buffered sample diluents, wash solutions, viral transport media, and antimicrobial supplements for culture media. These devices are designed for use in clinical and research laboratories.
Where is Clark Laboratories, Inc. based, and what does that mean for its regulatory oversight?
Clark Laboratories, Inc. is based in the United States, which means its devices are subject to FDA regulation. The FDA oversees IVDs in the U.S., requiring manufacturers to comply with specific classification rules (e.g., Class I or Class II) and regulatory pathways like the 510(k) premarket notification process or UDI registration. Since the company’s devices are listed in the FDA’s 510(k) and UDI databases, they are intended for commercial distribution within the U.S. market under FDA guidelines.
Which regulatory registries or databases list Clark Laboratories, Inc.’s devices?
Clark Laboratories, Inc.’s devices are recorded in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. The 510(k) database tracks submissions for devices deemed to be substantially equivalent to predicate devices, while the UDI system ensures standardized identification of medical devices for tracking and traceability. These listings reflect the regulatory pathway taken for individual devices rather than the company itself.
How are Clark Laboratories, Inc.’s devices classified under FDA regulations?
Clark Laboratories, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls (e.g., good manufacturing practices), while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential health impact, and the level of regulatory oversight required—determined by the FDA based on the specific device’s risk profile.
Why do some of Clark Laboratories, Inc.’s devices appear under multiple brand names like Trinity Biotech?
The brand names listed (e.g., Trinity Biotech) refer to the specific commercial or proprietary names under which Clark Laboratories, Inc.’s devices may be marketed or distributed. These names often reflect licensing agreements, collaborations, or rebranding for different markets or customer segments. While the underlying technology or manufacturing may originate from Clark Laboratories, the devices may be sold or promoted under these alternative brand names depending on contractual arrangements or regional preferences.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- trinityusa.com
- —
- —
- [email protected]
- Phone
- 1-800-325-3424
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 623214079
Catalogue (179)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trinity Biotech | 2325800 | FDA UDI | Class I | Active |
| Trinity Biotech | 2337170 | FDA UDI | Class II | Active |
| Trinity Biotech | 2325101 | FDA UDI | Class II | Active |
| Trinity Biotech | 2325350 | FDA UDI | Class II | Active |
| Bartels | B1029-35D | FDA UDI | Class I | Active |
| Trinity Biotech | 30550 | FDA UDI | Class II | Active |
| Trinity Biotech | 616134 | FDA UDI | Class II | Active |
| Bio-Rad | 72520 | FDA UDI | Class II | Active |
| Platelia | 827102 | FDA UDI | Class I | Active |
| Trinity Biotech | 827882 | FDA UDI | Class II | Active |
| Trinity Biotech | 2325001 | FDA UDI | Class I | Active |
| Immco | 230AWI | FDA UDI | Class II | Active |
| Trinity Biotech | 2325250 | FDA UDI | Class II | Active |
| Trinity Biotech | 618739 | FDA UDI | Class II | Active |
| Trinity Biotech | 2323801 | FDA UDI | Class II | Active |
| Vca Igg Elisa Test System | K980912 | FDA 510(k) | Class I | Active |
| Encore Scl-70 | K920150 | FDA 510(k) | Class II | Active |
| Ea-D Igg Elisa Test System | K973123 | FDA 510(k) | Class I | Active |
| Encore Sm/Rnp | K921870 | FDA 510(k) | Class II | Active |
| Vca Igm Elisa Test System | K980596 | FDA 510(k) | Class I | Active |
| Encore Sm | K921572 | FDA 510(k) | Class II | Active |
| Encore Thyroglobulin Ige, Iga And Igm Eia | K925826 | FDA 510(k) | Class II | Active |
| Encore Ds-Dna | K923537 | FDA 510(k) | Class II | Active |
| Rubella Igm | K921573 | FDA 510(k) | Class II | Active |
| Encore Ss-B | K922340 | FDA 510(k) | Class II | Active |
| Ebna-1 Igm Elisa Test System | K980598 | FDA 510(k) | Class I | Active |
| Encore Ena Combined Eia | K931543 | FDA 510(k) | Class II | Active |
| Encore Ss-A | K922157 | FDA 510(k) | Class II | Active |
| Encore Rheumatoid Factor Eia | K924056 | FDA 510(k) | Class II | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Clark Laboratories, Inc. has two recall records, both initiated in 2021—one on March 17 and the other on October 11—with both currently marked as terminated. The first involved a potential issue where the positive control could exceed its assigned ISR range, leading to invalid test results and requiring retesting. The second concerned conjugate contamination that may cause pipetting problems, potentially resulting in invalid assays.
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 11, 2021 | Z-0382-2022 | — | terminated | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay |
| Mar 17, 2021 | Z-1503-2021 | — | terminated | Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting |