Duns Number:790524891
Device Description: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of I Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19).
Catalog Number
GSD01-1029
Brand Name
Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
Version/Model Number
GSD01-1029
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 11, 2020
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
-
Product Code
QJR
Product Code Name
Reagents, 2019-Novel Coronavirus Nucleic Acid
Public Device Record Key
7e09f02b-42a7-49f4-85f2-980cb45e1464
Public Version Date
June 04, 2021
Public Version Number
3
DI Record Publish Date
May 20, 2020
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |