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Kalazar Detect™ Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref INS015Ref INS020
Identity
- Device Name
- Kalazar Detect™ Rapid Test EUDAMED
- Model / Reference
- INS015 EUDAMEDINS020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++B379INS015VS EUDAMED++B379INS0201E EUDAMED
- Basic UDI-DI
- B-++B379INS015VS EUDAMEDB-++B379INS0201E EUDAMED
- EMDN Code
- W0105090499 PARASITES - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
Kalazar Detect™ Rapid Test by InBios International, 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-++B379INS015VS | Class IVD General | Active |
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Manufacturer
- Manufacturer
- InBios International, Inc.
- EUDAMED SRN
- US-MF-000020625
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED aaf212aa-428d-429d-b8f3-29e508c92d67 61 fields · synced Jul 28, 2026
- EUDAMED 983ccf5d-1b91-4a48-ad07-10239f470250 61 fields · synced May 19, 2026