FDA Registration
Active
🇺🇸 United States
Alinity s Anti-HBc Reagent Kit (LN06P0656)
Reg #: 1415939
·
FEI: 1415939
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 1415939
- FEI Number
- 1415939
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 ABBOTT PARK RD.
- City
- Abbott Park
- State
- IL
- ZIP
- 60064
- 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 |
|---|---|---|---|---|---|
| Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations | QHM | Class U | Microbiology | No | 2025-05-21 |
Proprietary Names
Alinity s Anti-HBc Reagent Kit (LN06P0656)
Alinity s Syphilis Reagent Kit (LN06P0956)
Alinity s HIV Ag/Ab Combo Reagent Kit (LN06P0156)
Alinity s HBsAg Confirmatory Reagent Kit (LN06P0356)
Alinity s HBsAg Reagent Kit (LN06P0256)
Alinity s Chagas Reagent Kit (LN06P0856)
Alinity s Anti-HCV II Reagent Kit (LN04W5658)
Alinity s HTLV I/II Reagent Kit (LN06P0756)
Establishment Types
Manufacture Device in the United States for Export Only