FDA Registration
Active
🇺🇸 United States
Magellan Diagnostics, Inc.
Reg #: 1218996
·
FEI: 1218996
·
Expires 2026
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Magellan Diagnostics, Inc.
- Registration Number
- 1218996
- FEI Number
- 1218996
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 101 Billerica Ave Bldg 4
- City
- N Billerica
- State
- MA
- ZIP
- 01862
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052549
Owner / Operator
- Firm Name
- MAGELLAN Diagnostics INC.
- Operator Number
- 1218996
- Address
- 101 Billerica Ave Bldg 4, --
- City
- N Billerica
- State
- MA
- Postal Code
- 01862
- Country
- US
- Correspondent
- Vernon C Brown
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lead, Atomic Absorption | DOF | Class 2 | Clinical Toxicology | No | 2007-10-10 |
Proprietary Names
LeadCare II Blood Lead Testing Syst
LeadCare Plus
LeadCare Ultra
LeadCare Blood Lead Testing System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility