Identity
- Trade Name
- JB-2 Staining System EUDAMEDRESOLVE Systems JB-2 Staining System FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
- Device Name
- JB-2 Staining System EUDAMEDFor staining hemoglobin. FDA UDI
- Model / Reference
- FR-9367 EUDAMEDFDA UDI
- Description
- For staining hemoglobin. FDA UDI
Identifiers
- Catalog Number
- FR-9367 FDA UDI
- Primary DI / UDI-DI
- 06438147000807 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147RESOLVE_JB2G7 EUDAMED
- 510(k) Number
- K050709 FDA UDI
- FDA Product Code
- GKA FDA UDI
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7415 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
JB-2 Staining System by Wallac Oy — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147RESOLVE_JB2G7 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 532b9655-9141-4a69-87e0-c4e390a55481 61 fields · synced May 30, 2026
- FDA UDI 070868df-591b-4ca5-960f-1974b774b7d9 36 fields · synced May 29, 2026