Identity
- Trade Name
- Titan AP Fast Red 30mL Kit EUDAMEDTitan AP Fast Red 30 mL Kit FDA UDI
- Generic Name
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Titan AP Fast Red 30 mL Kit EUDAMEDA Fast Red Kit containing two components. Fast Red chromogen used in conjunction with AP polymer based detection system for tissue sample visualization. FDA UDI
- Model / Reference
- R2023-000 EUDAMED1 FDA UDI
- Description
- A Fast Red Kit containing two components. Fast Red chromogen used in conjunction with AP polymer based detection system for tissue sample visualization. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030271 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030R20230005H EUDAMED
- Direct Marketing DI
- 00850042030271 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
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 AP Fast Red 30mL 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 | 0850042030R20230005H | 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 4183c34a-846e-48e2-b94c-7265bf9d3e9a 61 fields · synced Jun 18, 2026
- FDA UDI 90d5baa0-8cea-4c34-97b0-b18ec408d3d6 34 fields · synced May 30, 2026