Identity
- Trade Name
- Hematoxylin 560 EUDAMEDLeica Biosystems FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Hematoxylin EUDAMEDHematoxylin 560 FDA UDI
- Model / Reference
- 3801571 EUDAMED000000000003801571 FDA UDI
- Description
- Hematoxylin 560 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20849832018081 EUDAMEDFDA UDI
- Basic UDI-DI
- 849832008UV EUDAMED
- Direct Marketing DI
- 00849832018087 EUDAMED
- FDA Product Code
- HYJ FDA UDI
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Category: Biological stain IVD
Leica Biosystems by Leica Biosystems Richmond, Inc. — 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
- Leica Biosystems Richmond, Inc.
Sources (2)
- FDA UDI fa286ce7-d793-408f-89d7-6c263513f235 36 fields · synced Aug 1, 2026
- EUDAMED 96fbaac4-5e3d-4de3-ba45-b0999840ba2e 61 fields · synced Aug 1, 2026