Duns Number:556915205
Device Description: BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
Catalog Number
DFA2-ASY-0004
Brand Name
BioFire® Global Fever Panel
Version/Model Number
DFA2-ASY-0004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN200043
Product Code
QMV
Product Code Name
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Public Device Record Key
069b320a-284f-4058-b376-b167df5f56cc
Public Version Date
July 26, 2021
Public Version Number
1
DI Record Publish Date
July 16, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |
| U | Unclassified | 1 |