FDA Registration
Active
🇺🇸 United States
Alinity c Multiconstituent Calibrator Kit (LN 08P6001)
Reg #: 3005333358
·
FEI: 3005333358
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 3005333358
- FEI Number
- 3005333358
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Conway Park, 675 North Field Drive
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2017-11-30 |
Proprietary Names
Alinity c Multiconstituent Calibrator Kit (LN 08P6001)
Alinity i Anti-CCP Calibrators (LN 09P2701)
Alinity c Bilirubin Calibrator Kit (LN 08P6101)
Alinity c Lipid Multiconstituent Calibrator Kit (LN 09P1403)
Alinity c Urine/CSF Protein Calibrator Kit (LN 08P7101)
Alinity c Iron Calibrator Kit (LN 04U7501)
Alinity c ICT Urine Calibrator Kit (LN 08P7001)
Alinity c ICT Serum Calibrator Kit (LN 08P6901)
Urine/CSF Protein Calibrator (LN 1E71-03)
Alinity c Carbon Dioxide Calibrator Kit (LN 08P7201)
Alinity c Specific Proteins Multiconstituent Calibrator Kit (LN 08P6201)
Lipid Multiconstituent Calibrator (LN 5P56-02)
Alinity c Clinical Chemistry Calibrator Kit (LN 08P6503)
ICT Serum Calibrator (LN 1E46-04)
Specific Proteins Multiconstituent Calibrator (LN 1E78-04)
Bilirubin Calibrator (LN 1E66-05)
ICT Urine Calibrator (LN 1E47-03)
Alinity c Plasmaproteins Cal 3x Kit (LN 08P6601)
Alinity c Proteins Calibrators (LN 08P6702)
Carbon Dioxide Calibrator (LN 1E64-03)
Multiconstituent Calibrator (LN 1E65-06)
Consolidated Chemistry Calibrator (Alinity c; LN 04V6201)
Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501)
Establishment Types
Complaint File Establishment per 21 CFR 820.198