Duns Number:005088112
Device Description: Cardiac Troponin I Calibrator, 2x6x1mL
Catalog Number
KC678
Brand Name
Dimension Vista® CTNI CAL
Version/Model Number
10445197
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 06, 2022
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
K053577
Product Code
JIT
Product Code Name
CALIBRATOR, SECONDARY
Public Device Record Key
0577c705-b7a6-49dd-9ff2-a2642b3dc419
Public Version Date
October 07, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |