FDA Registration
Active
🇸🇪 Sweden
Q-linea AB
Reg #: 3027320620
·
FEI: 3027320620
·
Expires 2026
Products
2
Proprietary Names
2
Establishment Types
2
Classifications
2
Registration Details
- Registration Name
- Q-linea AB
- Registration Number
- 3027320620
- FEI Number
- 3027320620
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Palmbladsgatan 1
- City
- Uppsala
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K221688
Owner / Operator
- Firm Name
- Q-linea AB
- Operator Number
- 10091083
- Address
- Dag Hammarskjolds vag 52A
- City
- Uppsala
- State
- SE-C
- Postal Code
- 75237
- Country
- SE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | Class 2 | Microbiology | No | 2024-06-27 |
| Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | SAN | Class 2 | Microbiology | No | 2024-06-27 |
Proprietary Names
ASTar System
ASTar BC G- Kit
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198