Duns Number:064608573
Device Description: ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 500T
Catalog Number
10994775
Brand Name
ADVIA Centaur TNIH 500T Kit
Version/Model Number
10994775
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171274
Product Code
MMI
Product Code Name
IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Public Device Record Key
fcbdcc85-f677-41eb-a762-0546f6aef0f9
Public Version Date
November 18, 2021
Public Version Number
4
DI Record Publish Date
August 10, 2018
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 |