Duns Number:354019424
Device Description: EliA SARS-CoV-2-Sp1 IgG Well
Catalog Number
DECC066630
Brand Name
EliA SARS-CoV-2-Sp1 IgG Well
Version/Model Number
DECC066630
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
-
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
QKO
Product Code Name
Reagent, coronavirus serological
Public Device Record Key
c1e61acb-5c8a-418f-b80f-537301e2d469
Public Version Date
January 29, 2021
Public Version Number
1
DI Record Publish Date
January 21, 2021
Package DI Number
07333066021201
Quantity per Package
4
Contains DI Package
07333066021287
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 225 |
2 | A medical device with a moderate to high risk that requires special controls. | 518 |