FDA Registration
Active
🇺🇸 United States
MEDTOX Diagnostics, Inc.
Reg #: 3011260354
·
FEI: 3011260354
·
Expires 2026
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MEDTOX Diagnostics, Inc.
- Registration Number
- 3011260354
- FEI Number
- 3011260354
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6624 Owens Drive
- City
- Pleasanton
- State
- CA
- ZIP
- 94588
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153683
Owner / Operator
- Firm Name
- MEDTOX DIAGNOSTICS, INC.
- Operator Number
- 1050155
- Address
- 1238 ANTHONY RD., --
- City
- Burlington
- State
- NC
- Postal Code
- 27215
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2026-05-18 |
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2021-10-21 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2021-10-21 |
Proprietary Names
Labcorp Comfort Draw
TrueSpin
Torq ZDrive MR, Ram Scientific
Torq MiniDrive2
Torq ZDrive MR, BD Microtainer
Establishment Types
Manufacture Medical Device