Identity
- Trade Name
- GeneXpert Infinity-48s System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- Additional catalog numbers: 900-0540L, 900-0540R FDA UDI
- Model / Reference
- INFINITY 48-48 FDA UDI
- Description
- Additional catalog numbers: 900-0540L, 900-0540R FDA UDI
Identifiers
- Catalog Number
- 900-0540 FDA UDI
- Primary DI / UDI-DI
- 07332940004316 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
GeneXpert Infinity-48s System by Cepheid — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cepheid
Sources (1)
- FDA UDI 6c9477c9-e61f-4c9b-bda8-56da61d18b21 37 fields · synced Jun 1, 2026