Duns Number:276816717
Device Description: VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS ins VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma.
Catalog Number
-
Brand Name
VIDAS® TROPONIN I Ultra
Version/Model Number
30448-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 29, 2018
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
MMI
Product Code Name
Immunoassay Method, Troponin Subunit
Public Device Record Key
794c6708-9936-45da-bd83-8814cb2a0ac5
Public Version Date
May 14, 2020
Public Version Number
4
DI Record Publish Date
August 31, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |