Duns Number:315028860
Device Description: Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)
Catalog Number
08469865160
Brand Name
Elecsys Troponin T Gen 5
Version/Model Number
08469865160
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201441
Product Code
MMI
Product Code Name
IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Public Device Record Key
6cf2136f-b2e1-418b-b3c4-a93788c2c016
Public Version Date
March 09, 2022
Public Version Number
1
DI Record Publish Date
March 01, 2022
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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 760 |
| 3 | A medical device with high risk that requires premarket approval | 63 |
| U | Unclassified | 4 |