Identity
- Trade Name
- Infinite F50 FDA UDI
- Generic Name
- Microplate reader IVD, automated/semi-automated FDA UDI
- Device Name
- The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software. FDA UDI
- Model / Reference
- 30084265 01 FDA UDI
- Description
- The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software. FDA UDI
Identifiers
- Catalog Number
- 30084265 FDA UDI
- Primary DI / UDI-DI
- 09120052070347 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Microplate reader IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 by Tecan Austria GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tecan Austria GmbH
Sources (1)
- FDA UDI df83ecf7-44bb-4f7b-8978-f55c24257699 36 fields · synced May 30, 2026