Duns Number:080890141
Device Description: Quidel Triage Total 5 Control 1
Catalog Number
88753
Brand Name
Triage
Version/Model Number
88753
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072892
Product Code
JJY
Product Code Name
Multi-analyte controls, all kinds (assayed)
Public Device Record Key
5033c349-44fb-421d-a781-6f0b98bdf625
Public Version Date
June 11, 2020
Public Version Number
2
DI Record Publish Date
November 01, 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 | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 20 |