Identity
- Trade Name
- Exdia TRF Plus FDA UDI
- Generic Name
- Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care FDA UDI
- Device Name
- Exdia TRF Plus EUDAMEDA reader for the Exdia cartridges (immunofluorescence assay). FDA UDI
- Model / Reference
- PD-FC20 EUDAMEDFDA UDI
- Description
- A reader for the Exdia cartridges (immunofluorescence assay). FDA UDI
Identifiers
- Catalog Number
- PD-FC20 FDA UDI
- Primary DI / UDI-DI
- 08800026300083 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000263PDFC20AY EUDAMED
- FDA Product Code
- JZT FDA UDI
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.4520 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Exdia TRF Plus by Precision Biosensor 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 | 88000263PDFC20AY | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Precision Biosensor Inc.
- EUDAMED SRN
- KR-MF-000034861
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 3fe44a19-3405-46e1-acad-2b61da0ddef9 61 fields · synced Jun 19, 2026
- FDA UDI df668127-ebd9-4d7c-be0a-85b2a5510a5b 34 fields · synced May 30, 2026