Duns Number:985307301
Device Description: AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test
Catalog Number
06S6020
Brand Name
ARCHITECT
Version/Model Number
06S6020
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
5d1c21f7-e828-4867-af66-308570eafd6e
Public Version Date
April 14, 2021
Public Version Number
1
DI Record Publish Date
April 06, 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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| 3 | A medical device with high risk that requires premarket approval | 47 |