FDA Registration
Active
🇺🇸 United States
Multi-4 CO-Oximeter Control - Level 3
Reg #: 3012775350
·
FEI: 3012775350
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Instrumentation Laboratory Co.
- Registration Number
- 3012775350
- FEI Number
- 3012775350
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 18B Independence Dr
- City
- Devens
- State
- MA
- ZIP
- 01434
- Country
- US
Owner / Operator
- Firm Name
- Instrumentation Laboratory Co.
- Operator Number
- 1217183
- Address
- 180 Hartwell Road, --
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- Carol - Marble
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2018-03-08 |
Proprietary Names
Multi-4 CO-Oximeter Control - Level 3
Avox-4 Co-Oximeter Control - L2
IL PVP
GEM ChemSTAT CVP 3
GEM ChemSTAT CVP 4
Multi-4 CO-Oximeter Control, Multi
GEM ChemSTAT CVP 1
GEM ChemSTAT CVP 2
Avox-4 Co-Oximeter Control - L3
Multi-4 CO-Oximeter Control - Level 2
Avox-4 Co-Oximeter Control - L1
Multi-4 CO-Oximeter Control - Level 1
ChemSTAT System Evaluator 2
GEM ChemSTAT PVP 1-5
Avox-4 Co-Oximeter Control
ChemSTAT System Evaluator 1
ChemSTAT System Evaluator 3
GEM System Evaluator 2
GEM System Evaluator 1
GEM CVP 5 tBili
GEM System Evaluator 3
Establishment Types
Repack or Relabel Medical Device