FDA Registration
Active
🇲🇽 Mexico
Abbott Laboratories de Mexico
Reg #: 3016244760
·
FEI: 3016244760
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Abbott Laboratories de Mexico
- Registration Number
- 3016244760
- FEI Number
- 3016244760
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carretera Mexico Queretaro Km. 34.5, Colonia Rancho San Isidro
- City
- Cuautitlan Izcalli Mexico
- Country
- MX
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
US Agent
- Business Name
- ABBOTT LABORATORIES
- Contact Name
- Sara Qadri
- Address
- 675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
- [email protected]
- Phone
- 224 6680142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-05-03 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2018-05-03 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2024-06-05 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2024-06-05 |
Proprietary Names
Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131)
Alinity i System Accessories
Alinity i System
Alinity i Refurbished Processing Module (LN 03R65-84)
ARCHITECT System Accessories
ARCHITECT System
Alinity c System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)