Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
QFS is the FDA product code for Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QFS
- Device name
- Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
- FDA definition
- An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis.
- Regulation
- 21 CFR 866.3215
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QFS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2019 | 1 |
Applicants with the most clearances
Product code QFS| Applicant | Clearances |
|---|---|
| Siemens Healthcare Diagnostics Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.