Duns Number:317134468
Device Description: The DRG Brucella IgG Enzyme Immunoassay Kit provides materials for the qualitative and sem The DRG Brucella IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Brucella in human serum and plasma.
Catalog Number
EIA-3455
Brand Name
Brucella IgG ELISA
Version/Model Number
EIA-3455
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
-
Product Code
GSO
Product Code Name
ANTIGENS (FEBRILE), AGGLUTINATION, BRUCELLA SPP.
Public Device Record Key
5fcc32d9-e294-4bf8-a3d6-2fff5ad797f2
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
June 10, 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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |