Duns Number:164880598
Device Description: DRI™ Fentanyl II Negative Calibrator (Thermo Fisher) is intended for use in the calibratio DRI™ Fentanyl II Negative Calibrator (Thermo Fisher) is intended for use in the calibration of the DRI™ Fentanyl II Assay.
Catalog Number
10028874
Brand Name
DRI™ Fentanyl II Negative Calibrator
Version/Model Number
10028874
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
-
Product Code
DLJ
Product Code Name
Calibrators, Drug Specific
Public Device Record Key
83ebc369-fd44-442d-9e95-7afda1170605
Public Version Date
June 04, 2021
Public Version Number
1
DI Record Publish Date
May 27, 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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| U | Unclassified | 4 |