FDA Registration
Active
🇺🇸 United States
Alinity c Tox Semiquant Calibrators (LN 08P6801)
Reg #: 3005333358
·
FEI: 3005333358
·
Expires 2025
Products
1
Proprietary Names
9
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 |
|---|---|---|---|---|---|
| Calibrators, Drug Mixture | DKB | Class 2 | Clinical Toxicology | No | 2019-11-29 |
Proprietary Names
Alinity c Tox Semiquant Calibrators (LN 08P6801)
Alinity c Tox Qual Calibrators (LN 08P6802)
Alinity c Benzodiazepines Qual Calibrator Kit (LN 09P5201)
Alinity c TDM Multiconstituent Calibrator Kit (LN 08P7403, 08P7404)
Alinity c DOA MC Qual Low Calibrator 1 Kit (LN 08P6301)
Alinity c DOA MC Negative Calibrator Kit (LN 08P6305, 08P6306)
Alinity c DOA MC Semiquant Calibrator Kit (LN 08P6303)
Alinity c DOA MC Qual Calibrator 2 Kit (LN 08P6302)
Alinity c Benzodiazepines Semiquant Calibrator Kit (LN 09P5202)
Establishment Types
Complaint File Establishment per 21 CFR 820.198