Identity
- Trade Name
- Titan HRP DAB 30 mL Kit EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Titan HRP DAB 30 mL Kit EUDAMEDA DAB kit containing two components. DAB chromogen used in conjunction with polymer based detection system for tissue sample visualization. FDA UDI
- Model / Reference
- R2013-000 EUDAMED1 FDA UDI
- Description
- A DAB kit containing two components. DAB chromogen used in conjunction with polymer based detection system for tissue sample visualization. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030264 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R201300056 EUDAMED
- Direct Marketing DI
- 00850042030264 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
- GMDN Term
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Titan HRP DAB 30 mL 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 | 0850042030R201300056 | 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 82340d98-138f-467c-966c-89967c1ade0a 61 fields · synced Jul 15, 2026
- FDA UDI f5d1bbda-1d83-41be-8d85-9a3dd089e730 34 fields · synced May 30, 2026