Duns Number:075150847
Device Description: The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative andsemiquantitative determination of IgG-class antibodies to Candida albicans in serum.
Catalog Number
EIA-3458
Brand Name
Candida albicans IgG ELISA
Version/Model Number
EIA-3458
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LSG
Product Code Name
CANDIDA SPECIES, ANTIBODY DETECTION
Public Device Record Key
b2a9192c-9188-4a25-900c-8e1ab71f5b1e
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
March 20, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |