Duns Number:878252071
Device Description: OneStep Troponin I RapiCard™ InstaTest (Serum/WB)A collection of reagents and other associ OneStep Troponin I RapiCard™ InstaTest (Serum/WB)A collection of reagents and other associated materials intended to be used for the qualitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
Catalog Number
166772-1-19
Brand Name
RapiCard™ InstaTest
Version/Model Number
DACD166772-1-19
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
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
1e4070b8-d92a-4dc5-a9d9-9a877ca0d7d6
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2021
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |