Duns Number:064608573
Device Description: High Sensitivity Troponin I (TnIH) - Atellica IM - RGT 500T
Catalog Number
11206269
Brand Name
Atellica IM TNIH
Version/Model Number
11206269
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
K171566
Product Code
MMI
Product Code Name
IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Public Device Record Key
e4a160e0-7ff7-475a-82f4-53aded96ddcf
Public Version Date
November 18, 2021
Public Version Number
3
DI Record Publish Date
May 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 | 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 |