FDA Product Code
FDA Product Code QVR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.4000
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026-08-07 | Dual Track | PDF ↗ |
| K231336 | T2 Biothreat Panel | T2biosystems, Inc. | 2023-09-15 | Traditional | PDF ↗ |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | Biofire Defense, LLC | 2023-03-22 | Traditional | PDF ↗ |
Product code QVR · Class II · Immunology. Data: openFDA.