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Sign in to claim this brandE-Y Laboratories, Inc.
US
Last updated May 31, 2026
What E-Y Laboratories, Inc. makes
E-Y Laboratories, Inc. manufactures in vitro diagnostic (IVD) devices for rapid clinical testing, including antigen detection kits for beta-haemolytic Group A Streptococcus and specimen collection kits for sexually transmitted infection (STI) testing. Products include reagent tubes, test strips, and kits designed for point-of-care use in clinical settings.
The company’s devices are classified as Class I under FDA regulations and are listed 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 E-Y Laboratories, Inc. manufacture?
E-Y Laboratories, Inc. specializes in in vitro diagnostic (IVD) devices used for rapid clinical testing. Their primary products include antigen detection kits for beta-haemolytic Group A Streptococcus infections, such as reagent tubes and test strips (e.g., Strep-A-Chek), as well as specimen collection kits for sexually transmitted infection (STI) testing. These devices are designed for point-of-care use in clinical settings, enabling quick diagnostic results.
Where is E-Y Laboratories, Inc. based, and what does this mean for its regulatory oversight?
E-Y Laboratories, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s jurisdiction ensures that these products meet safety, performance, and labeling standards before they are authorized for market distribution, particularly through pathways like the 510(k) premarket notification process.
Which regulatory registries or databases list E-Y Laboratories, Inc.’s devices?
E-Y Laboratories, Inc.’s devices are listed in the FDA’s 510(k) database, which tracks premarket notifications for Class I medical devices, and the FDA’s Unique Device Identifier (UDI) system. These registries help ensure transparency and traceability of the devices in the market, allowing healthcare providers and regulators to verify product details and compliance.
How are E-Y Laboratories, Inc.’s devices classified under FDA regulations, and why does this matter?
E-Y Laboratories, Inc.’s devices are classified as Class I under FDA regulations. This classification applies to low-risk devices that pose minimal potential harm to users. Class I devices typically require general controls (such as good manufacturing practices) and may not need a premarket submission unless they are modified or present new risks. The classification reflects the relatively simple design and low-risk nature of their antigen detection kits and STI specimen collection tools.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- eylabs.com
- —
- —
- [email protected]
- Phone
- 6503423296
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 087212858
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gonochek®-II Reagent Tubes | 13-003-25 | FDA UDI | N/A | Active |
| EY-20(TM) Reagent Tube | 13-020-50 | FDA UDI | N/A | Active |
| Strep-A-Chek(TM) Strips (100 pcs) | 13-051-00 | FDA UDI | N/A | Active |
| Strep-A-Chek(TM) Kit | 13-050-00 | FDA UDI | N/A | Active |
| Strep-A-Chek | K842600 | FDA 510(k) | Class I | Active |
| Swabzyme Oxidase | K934130 | FDA 510(k) | Class I | Active |
| B-Lactamase Reagent Tubes | K940161 | FDA 510(k) | Class I | Active |
| Gonochek Ii Reagent Tubes | K940162 | FDA 510(k) | Class I | Active |
| Strep-A-Chek Tube | K840884 | FDA 510(k) | Class I | Active |
| Strep-A-Chek(tm) Reagent Strips | K940020 | FDA 510(k) | Class I | Active |
| Ey-20 Reagent Tubes | K940124 | FDA 510(k) | Class I | Active |
| Strep-A-Chek | K934129 | FDA 510(k) | Class I | Active |
| Gonochek-Ii, Modification | K934125 | FDA 510(k) | Class I | Active |
| E-Coli-Chek Tube | K844276 | FDA 510(k) | Class I | Active |
| Gonochek Panel | K830756 | FDA 510(k) | Class I | Active |
| Gonochek-Ii | K833180 | FDA 510(k) | Class I | Active |
| Swabzyme-Oxidase | K840810 | FDA 510(k) | Class I | Active |
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