Duns Number:197934250
Device Description: For use as a consistent test sample of known concentration for monitoring assay conditions For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE.
Catalog Number
K94C-2M
Brand Name
K-ASSAY® Total IgE Control
Version/Model Number
K94C-2M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 16, 2022
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
-
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
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
04b2157a-f511-466c-bc4a-45228a2df243
Public Version Date
August 17, 2022
Public Version Number
2
DI Record Publish Date
January 25, 2019
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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |