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ASTar BC G- Kit software CE-IVDR
EUDAMEDFDA 510(k)Class C (EU MDR)
Ref 50005392
by Q-linea AB
Identity
- Trade Name
- ASTar BC G- Kit software CE-IVDR EUDAMED
- Device Name
- ASTar BC G- Kit software CE-IVDR EUDAMED
- Model / Reference
- 50005392 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350136800351 EUDAMED
- Basic UDI-DI
- 735013680500053925Y EUDAMED
- EMDN Code
- W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Category: General-microorganism antimicrobial susceptibility culture medium IVD
ASTar BC G- Kit software CE-IVDR by Q-Linea AB — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253573 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 735013680500053925Y | Class C | Active |
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Manufacturer
- Manufacturer
- Q-linea AB
- EUDAMED SRN
- SE-MF-000013026
Sources (2)
- EUDAMED 62ce42da-a6a7-49da-96ce-60a097ade1ee 61 fields · synced Jun 19, 2026
- FDA 510(k) K253573 1 fields · synced May 18, 2026