Duns Number:045623154
Device Description: The Troponin I assay is intended for the quantitative determination of cardiac troponin I The Troponin I assay is intended for the quantitative determination of cardiac troponin I (cTnI) in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI). For in vitro diagnostic use. 96 Tests.
Catalog Number
CM1105-96
Brand Name
Pointe Scientific, Inc.
Version/Model Number
CM1105-96
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
K013062
Product Code
MMI
Product Code Name
Immunoassay Method, Troponin Subunit
Public Device Record Key
ed9d557b-8ed2-47ce-b06f-0c18845cd38e
Public Version Date
July 06, 2018
Public Version Number
3
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |