Identity
- Trade Name
- Titan Double Stain Kit EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Titan Double Stain Kit EUDAMEDA Detection System Kit with Double Stain containing 5 components. Mixed Polymer based detection system used in conjunction with DAB and Fast Red chromogens for tissue sample visualization. FDA UDI
- Model / Reference
- R2030-000 EUDAMED1 FDA UDI
- Description
- A Detection System Kit with Double Stain containing 5 components. Mixed Polymer based detection system used in conjunction with DAB and Fast Red chromogens for tissue sample visualization. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030257 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R203000057 EUDAMED
- Direct Marketing DI
- 00850042030257 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
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
Yes
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
Titan Double Stain Kit 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 | 0850042030R203000057 | 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 f9dce042-c132-4406-b1b9-93dc89d5c803 61 fields · synced Jun 19, 2026
- FDA UDI cccb9531-423c-4b48-8e9b-4a8552e4b1ae 34 fields · synced May 30, 2026