Duns Number:079226216
Device Description: CARTRIDGE, cTnI
Catalog Number
06P23-25
Brand Name
i-STAT
Version/Model Number
06P23-25
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
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
Yes
Prescription Use (Rx)
-
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
bfbc6b4e-86df-4d61-b1a7-30e324cf0c4e
Public Version Date
March 25, 2022
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
00054749001989
Quantity per Package
25
Contains DI Package
10054749001986
Package Discontinue Date
December 31, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |
| 3 | A medical device with high risk that requires premarket approval | 14 |