FDA Registration
Active
🇺🇸 United States
Validate Vitamin D product code 506vt
Reg #: 1226774
·
FEI: 3003407015
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LGC Clinical Diagnostics, Inc.
- Registration Number
- 1226774
- FEI Number
- 3003407015
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 221 US Route 1
- City
- Cumberland Foreside
- State
- ME
- ZIP
- 04110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113524
Owner / Operator
- Firm Name
- LGC Clinical Diagnostics, Inc.
- Operator Number
- 9041170
- Address
- 37 Birch Street, --
- City
- Milford
- State
- MA
- Postal Code
- 01757
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2021-11-30 |
Proprietary Names
Validate Vitamin D product code 506vt
Validate VIT D product code 506
VALIDATE VIT D Calibration Verification / Linearity Test Kit
Validate Vitamin D Calibration Verification/ Linearity Test Kit, product code 506ab
Establishment Types
Manufacture Medical Device