Duns Number:005088112
Device Description: Cardiac Troponin I Flex® reagent cartridge, 120 tests
Catalog Number
K6421
Brand Name
Dimension Vista® Flex® reagent cartridge CTNI
Version/Model Number
10445098
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 25, 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
K063756,K063756
Product Code
MMI
Product Code Name
IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Public Device Record Key
3bcf6a46-4035-4060-8706-37fa2e4313a3
Public Version Date
July 29, 2022
Public Version Number
7
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 |