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Artron ONE STEP Tuberculosis Antibody (TB Ab) Test
EUDAMEDClass IVD General (EU MDR)
Ref A03-07-222Model Cassette
Identity
- Trade Name
- Artron ONE STEP Tuberculosis Antibody (TB Ab) Test EUDAMED
- Device Name
- ONE STEP Tuberculosis Antibody (TB Ab) Test EUDAMED
- Model / Reference
- Cassette EUDAMEDA03-07-222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347561383 EUDAMED
- Basic UDI-DI
- B-00628347561383 EUDAMED
- EMDN Code
- W0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Artron ONE STEP Tuberculosis Antibody (TB Ab) Test by Artron Laboratories Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00628347561383 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 09be3b46-4b23-4158-bc18-e69af6048712 61 fields · synced Jul 21, 2026