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Titan Prime Universal AP Polymer Detection Kit with Fast Red
EUDAMEDFDA UDIClass A (EU MDR)
Ref R2020-000
Identity
- Trade Name
- Titan Prime Universal AP Polymer Detection Kit with Fast Red EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Titan Prime Universal AP Polymer Detection Kit with Fast Red EUDAMEDA Detection System Kit containing four components. Polymer based detection system used in conjunction with Fast Red chromogen to allow for the visualization of tissue samples. FDA UDI
- Model / Reference
- R2020-000 EUDAMED1 FDA UDI
- Description
- A Detection System Kit containing four components. Polymer based detection system used in conjunction with Fast Red chromogen to allow for the visualization of tissue samples. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030202 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R20200004U EUDAMED
- Direct Marketing DI
- 00850042030202 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
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 Prime Universal AP Polymer Detection Kit with Fast Red by Lumatas Biosystems, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0850042030R20200004U | 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 446c0ec6-9e55-4875-9642-ca99ae4c6dcc 61 fields · synced Jul 14, 2026
- FDA UDI df98a04a-14cd-456d-8c5a-3022c0fd4fc3 34 fields · synced May 30, 2026