Duns Number:008254708
Device Description: Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiactroponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay Systems to aid in the diagnosisof myocardial infarction (MI).
Catalog Number
B52699
Brand Name
Access hsTnI
Version/Model Number
B52669
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
-
Product Code
MMI
Product Code Name
Immunoassay Method, Troponin Subunit
Public Device Record Key
a33c8641-ac63-47b6-b8fb-1188814836aa
Public Version Date
September 27, 2018
Public Version Number
1
DI Record Publish Date
August 27, 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 | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |