Duns Number:197934250
Device Description: For the quantitative determination of human total IgE in serum or plasma by immunoturbidim For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.
Catalog Number
KAI-092
Brand Name
K-ASSAY® Total IgE Reagent
Version/Model Number
KAI-092
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
-
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
K042241
Product Code
DGC
Product Code Name
Ige, Antigen, Antiserum, Control
Public Device Record Key
a360d44d-fd8b-4f5f-88e8-95b483d0c279
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 16, 2016
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 |