Identity
- Trade Name
- INFINITE F50 PLUS EUDAMEDFDA UDI
- Generic Name
- Microplate reader IVD, automated/semi-automated FDA UDI
- Device Name
- Infinite F50 Plus EUDAMEDThe Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes Magellan™ reader control and data analysis software. FDA UDI
- Model / Reference
- 30183570 EUDAMED30183570 00 FDA UDI
- Description
- The Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes Magellan™ reader control and data analysis software. FDA UDI
Identifiers
- Catalog Number
- 30183570 FDA UDI
- Primary DI / UDI-DI
- 09120052071146 EUDAMEDFDA UDI
- Basic UDI-DI
- 912005207IVS10080000ANZ EUDAMED
- FDA Product Code
- JJQ FDA UDI
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
- GMDN Term
- Microplate reader IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2300 FDA UDI
- Market of Registration
- Austria 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Infinite F50 Plus by Tecan Austria GmbH — 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 | 912005207IVS10080000ANZ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tecan Austria GmbH
- EUDAMED SRN
- AT-MF-000020241
Sources (2)
- EUDAMED 25ba6f42-301f-4c78-9630-0d63d2437276 61 fields · synced Jun 18, 2026
- FDA UDI d0ebd0a9-b867-4447-b7a1-6b8c147363d6 35 fields · synced May 30, 2026