Duns Number:317134468
Device Description: Enzyme immunoassay for the quantitative determination of IgG class antibodies against Diph Enzyme immunoassay for the quantitative determination of IgG class antibodies against Diphtheria in human serum and plasma.
Catalog Number
EIA-2514
Brand Name
Diphtheria IgG ELISA
Version/Model Number
EIA-2514
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
GOS
Product Code Name
ANTISERUM, FLUORESCENT, C. DIPHTHERIAE
Public Device Record Key
f7336e2d-db4a-434b-9fe9-94d4afcb6997
Public Version Date
June 15, 2021
Public Version Number
1
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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |