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CQI KD-Ag/P.falciparum
EUDAMEDClass B (EU MDR)
Ref Mt21Pf1/3Model CQI KD-Ag/P. falciparum
by KaliDiv
Identity
- Trade Name
- CQI KD-Ag/P.falciparum EUDAMED
- Model / Reference
- CQI KD-Ag/P. falciparum EUDAMEDMt21Pf1/3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770040619087 EUDAMED
- Basic UDI-DI
- 3770040619CQIAGPCRPFALTC EUDAMEDB-03770040619087 EUDAMED
- EMDN Code
- W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
No
EUDAMED
Category: Multiple bacteria species culture isolate identification control IVD, kit
CQI KD-Ag/P.falciparum by KaliDiv — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 3770040619CQIAGPCRPFALTC | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 3770040619CQIAGPCRPFALTC | Class B | Active |
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Manufacturer
- Manufacturer
- KaliDiv
- EUDAMED SRN
- FR-MF-000047430
Sources (2)
- EUDAMED bef56f40-192b-4428-8762-6912e11edcde 61 fields · synced Aug 3, 2026
- EUDAMED feee0bb1-2df0-43fa-9115-5ad3d314b3e7 61 fields · synced Aug 3, 2026