Duns Number:075150847
Device Description: The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in hu The DRG IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
Catalog Number
EIA-1788
Brand Name
Immunoglobulin E (IgE) ELISA
Version/Model Number
EIA-1788
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
K992528
Product Code
DGC
Product Code Name
IGE, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
5a8d8616-247a-497c-bdf2-9b7a6176e56b
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 07, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |