← Back to catalogue
Ral Diff-Quik Solution II (1 x 2, 5L)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 720580-2500
Identity
- Trade Name
- RAL Diff-Quik™ solution II EUDAMEDRal Diff-Quik Solution II (1 x 2,5L) FDA UDI
- Generic Name
- Romanowsky stain IVD, kit FDA UDI
- Device Name
- RAL Diff-Quik™ solution II EUDAMED
- Model / Reference
- 720580-2500 EUDAMED03760177194557 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760177194557 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017719720580L2 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 II (1 x 2, 5L) by R.a.l. Diagnostics — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Romanowsky stain IVD, kit.
- Camco — CAMBRIDGE DIAGNOSTIC PRODUCTS, INC. · Class I
- Camco — CAMBRIDGE DIAGNOSTIC PRODUCTS, INC. · Class I
- Camco — CAMBRIDGE DIAGNOSTIC PRODUCTS, INC. · Class I
- Ral Diff-Quik EZ-Kit (3 x 100ml) — R.A.L. DIAGNOSTICS · Class I
- Ral Diff-Quik Kit (3 x 500ml) — R.A.L. DIAGNOSTICS · Class I
- Ral Diff-Quik Fixative Solution (1 x 2, 5L) — R.A.L. DIAGNOSTICS · Class I
- Ral Diff-Quik Solution I (1 x 2, 5L) — R.A.L. DIAGNOSTICS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R.a.l. Diagnostics
Sources (2)
- FDA UDI 8b1e9669-29c3-4d20-80c7-18cb27b7e259 32 fields · synced Jun 11, 2026
- EUDAMED 6190a432-dfd4-4fa8-9252-a97caab07e65 61 fields · synced Jun 11, 2026