Duns Number:195501127
Device Description: For use only with the UltraCrit™ hematocrit measurement device and UltraCrit quality contr For use only with the UltraCrit™ hematocrit measurement device and UltraCrit quality control (QC) cuvettes.
Catalog Number
300-118
Brand Name
UltraChek Reference Controls High
Version/Model Number
300-118
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
GKF
Product Code Name
Instrument, Hematocrit, Automated
Public Device Record Key
d4f7c9c9-79f9-4fe6-a0dc-4034c83729e7
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
August 25, 2017
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. | 11 |