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IGH Gene Clonality Assay
EUDAMEDClass IVD General (EU MDR)
Ref 9-101-0061Ref 9-101-0081
Identity
- Trade Name
- IGH Gene Clonality Assay EUDAMED
- Device Name
- IGH Gene Clonality Assay for ABI Fluorescence Detection EUDAMEDIGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection EUDAMED
- Model / Reference
- 9-101-0061 EUDAMED9-101-0081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850052003142 EUDAMED00850052003159 EUDAMED
- Basic UDI-DI
- B-00850052003142 EUDAMEDB-00850052003159 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
IGH Gene Clonality Assay by Invivoscribe, 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-00850052003142 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Invivoscribe, Inc.
- EUDAMED SRN
- US-MF-000011736
- Authorised Representative
- IN VIVOSCRIBE TECHNOLOGIES FR-AR-000003774
Sources (2)
- EUDAMED c7cff68f-680b-4d4d-8efe-530336f8ba41 61 fields · synced Aug 1, 2026
- EUDAMED ea14020a-cb50-49cc-92c5-0ef9508f58a8 61 fields · synced May 18, 2026