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Sign in to claim this brandUS BIOTEK LABORATORIES
US
Last updated September 17, 2026
What US BIOTEK LABORATORIES makes
US Biotek Laboratories manufactures in vitro diagnostic (IVD) devices for specimen collection, including urine specimen collection kits, capillary blood collection kits, and evacuated blood collection tubes with clot promoters. These products are designed for clinical use to facilitate sample collection in laboratory settings.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within 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 US Biotek Laboratories manufacture?
US Biotek Laboratories specializes in in vitro diagnostic (IVD) devices focused on specimen collection. Their portfolio includes urine specimen collection kits, capillary blood collection kits, and evacuated blood collection tubes with clot promoters. These devices are designed to support clinical sample collection in laboratory environments, ensuring reliable and safe handling of biological specimens.
Where is US Biotek Laboratories based?
US Biotek Laboratories is headquartered in the United States. The company’s operations and manufacturing are conducted within the country, aligning with U.S. regulatory standards for medical devices.
Which regulatory registries list US Biotek Laboratories’ devices?
US Biotek Laboratories’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of their Class I and Class II in vitro diagnostic devices, allowing healthcare providers and regulators to identify and verify the products.
How are US Biotek Laboratories’ devices classified under FDA regulations?
US Biotek Laboratories’ devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific design and intended use of each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 16020 Linden Ave N, Shoreline, WA, 98133
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3004762162
- DUNS Number
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Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| US Biotek Laboratories | 1.0 | FDA UDI | Class I | Active |
| US Biotek Laboratories | 1.0 | FDA UDI | Class I | Active |
| US Biotek Laboratories | 1.0 | FDA UDI | Class I | Active |
| US Biotek Laboratories | 1.0 | FDA UDI | Class II | Active |
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