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Ral Diff-Quik Solution I (1 x 2, 5L)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 720570-2500
Identity
- Trade Name
- RAL Diff-Quik™ solution I EUDAMEDRal Diff-Quik Solution I (1 x 2,5L) FDA UDI
- Generic Name
- Romanowsky stain IVD, kit FDA UDI
- Device Name
- RAL Diff-Quik™ solution I EUDAMED
- Model / Reference
- 720570-2500 EUDAMED03760177194540 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760177194540 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017719720570KX EUDAMED
- FDA Product Code
- KQC FDA UDI
- EMDN Code
- W0103010399 HAEMATOLOGY STAINS FOR MICROSCOPY - OTHER EUDAMED
- GMDN Term
- Romanowsky stain IVD, kit FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- France 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Romanowsky stain IVD, kit
Ral Diff-Quik Solution I (1 x 2, 5L) by R.a.l. Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- R.a.l. Diagnostics
Sources (2)
- FDA UDI 46bd6429-2763-482d-b2be-a337dfb66beb 32 fields · synced Jun 18, 2026
- EUDAMED 6377fa86-5457-46f5-b449-e0154a7af821 61 fields · synced Jun 18, 2026