Identity
- Trade Name
- Hematoxylin Solution EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry signal amplification reagent IVD FDA UDI
- Device Name
- Hematoxylin Solution EUDAMEDNuclear counterstain FDA UDI
- Model / Reference
- R1041-030 EUDAMED1 FDA UDI
- Description
- Nuclear counterstain FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030158 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R10410305H EUDAMED
- Direct Marketing DI
- 00850042030158 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
- GMDN Term
- Immunohistochemistry signal amplification reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hematoxylin Solution by Lumatas Biosystems, Inc. — 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 | 0850042030R10410305H | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Lumatas BioSystems Inc
- EUDAMED SRN
- US-MF-000017316
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (2)
- EUDAMED da727dea-d15b-4936-bab2-33a7054d45cc 61 fields · synced Jun 19, 2026
- FDA UDI d60cf1c5-7cdc-428b-9ac8-f176a2fca371 34 fields · synced May 30, 2026