Duns Number:079226220
Device Description: SARS-CoV-2 IgG Calibrator Kit
Catalog Number
06R9001
Brand Name
Alinity
Version/Model Number
06R9001
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
a561ebb2-ac3b-479a-9c47-c6d0a93c1241
Public Version Date
June 02, 2020
Public Version Number
1
DI Record Publish Date
May 25, 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 | 259 |
2 | A medical device with a moderate to high risk that requires special controls. | 245 |
U | Unclassified | 5 |