Titan Prime Universal HRP Polymer Detection Kit with DAB
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Titan Prime Universal HRP Polymer Detection Kit with DAB EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Titan Prime Universal HRP Polymer Detection Kit with DAB EUDAMEDA Detection System Kit containing four components. Polymer based detection system used in conjunction with DAB chromogen to allow for visualization of the tissue sample. FDA UDI
- Model / Reference
- R2010-000 EUDAMED1 FDA UDI
- Description
- A Detection System Kit containing four components. Polymer based detection system used in conjunction with DAB chromogen to allow for visualization of the tissue sample. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030097 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R20100004H EUDAMED
- Direct Marketing DI
- 00850042030097 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
- 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
Titan Prime Universal HRP Polymer Detection Kit with DAB by Lumatas Biosystems, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 0850042030R20100004H | 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 dfd4fe28-56db-4329-a1a1-1cd02cb08440 61 fields · synced Jul 15, 2026
- FDA UDI 0693813f-4c03-42fa-8df0-f028e64a4b15 34 fields · synced May 30, 2026