FDA Registration
Active
🇺🇸 United States
Alinity m Specimen Buffer Kit III
Reg #: 3005248192
·
FEI: 3005248192
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT MOLECULAR, INC.
- Registration Number
- 3005248192
- FEI Number
- 3005248192
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1300 EAST TOUHY AVENUE
- City
- Des Plaines
- State
- IL
- ZIP
- 60018
- 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 |
|---|---|---|---|---|---|
| Kit, Dna Detection, Human Papillomavirus | MAQ | Class 3 | Unknown | No | 2019-01-30 |
Proprietary Names
Alinity m Specimen Buffer Kit III
Alinity m HR HPV AMP Kit (List 09N15-092)
Alinity m HR HPV Amplification Kit, Alinity m HPV Control Kit
Alinity m HR HPV Application Specification File
simpli-COLLECT HPV Collection Kit
Alinity m Specimen Buffer Kit II
simpli-COLLECT HPV Collection Kit (LN 09R03-033)
Establishment Types
Manufacture Device in the United States for Export Only