Identity
- Trade Name
- DAB Away Kit EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- DAB Away Kit EUDAMEDA cleaning kit containing three components. Used for the removal of DAB from Automated Tissue Staining Instrument. FDA UDI
- Model / Reference
- R3010-000 EUDAMED1 FDA UDI
- Description
- A cleaning kit containing three components. Used for the removal of DAB from Automated Tissue Staining Instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030165 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R301000052 EUDAMED
- Direct Marketing DI
- 00850042030165 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
DAB Away Kit by Lumatas Biosystems, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850042030R301000052 | 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 5f235e09-09e5-452a-9923-b7bc320b60a8 61 fields · synced Jun 18, 2026
- FDA UDI c9d03ab3-f80d-4bed-8e11-08ffe15f6077 34 fields · synced May 30, 2026