FDA Registration
Active
🇺🇸 United States
CELL-DYN WBC Reagent - Part B (LN 01H78-01/01H78-02)
Reg #: 3016438761
·
FEI: 3016438761
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 3016438761
- FEI Number
- 3016438761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1915 Hurd Drive
- City
- Irving
- State
- TX
- ZIP
- 75038
- 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 |
|---|---|---|---|---|---|
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 1994-09-21 |
Proprietary Names
CELL-DYN WBC Reagent - Part B (LN 01H78-01/01H78-02)
CELL-DYN CN Free HGB/NOC Lyse (LN 03H80-02)
CELL-DYN CN-Free HGB Reagent (LN 01H79-01)
CELL-DYN WBC Lyse (LN 08H52-01)
CELL-DYN Emerald CN-Free Lyse (LN 09H47-02)
CELL-DYN Emerald 22 Lyse (LN 09H6101)
Alinity h-series HGB Reagent (LN 07P8104)
CELL-DYN WBC Reagent - Part A (LN 01H77-01/01H77-02)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility