Duns Number:784143778
Device Description: The Total IgE ELISA is intended for use in the quantitative determination of immunoglobuli The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
Catalog Number
25-IGEHU-E01
Brand Name
Total IgE ELISA
Version/Model Number
25-IGEHU-E01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 19, 2019
Issuing Agency
In HIBCC
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
K992528
Product Code
DGC
Product Code Name
Ige, Antigen, Antiserum, Control
Public Device Record Key
4936a725-0199-48d6-b660-30ca372f0bff
Public Version Date
September 20, 2022
Public Version Number
4
DI Record Publish Date
August 03, 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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |