Duns Number:078742335
Device Description: LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abbott System LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abbott Systems, Level BLiniCAL Cardiac CalVer for Abbott Systems, Level CLiniCAL Cardiac CalVer for Abbott Systems, Level DLiniCAL Cardiac CalVer for Abbott Systems, Level E
Catalog Number
-
Brand Name
Cardiac CalVer for Abbott Systems, Level A-E
Version/Model Number
98602
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080973
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
de7a5774-f0b2-4446-9cc3-7e86d1eed62d
Public Version Date
August 31, 2020
Public Version Number
2
DI Record Publish Date
July 31, 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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |