Duns Number:051624070
Device Description: InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac mar InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers control.)
Catalog Number
12009963
Brand Name
InteliQ
Version/Model Number
12009963
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
JJY
Product Code Name
Multi-analyte controls, all kinds (assayed)
Public Device Record Key
aaaad990-a8f6-46be-a51e-00b70fed92d0
Public Version Date
September 10, 2020
Public Version Number
1
DI Record Publish Date
September 02, 2020
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 | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |