Duns Number:060467826
Device Description: KWIK-STIK™ N. gonorrhoeae CDC P681E
Catalog Number
01273U
Brand Name
KWIK-STIK™
Version/Model Number
01273U
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2021
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
JTR
Product Code Name
KIT, QUALITY CONTROL FOR CULTURE MEDIA
Public Device Record Key
b558b623-f9fe-4d67-bde0-4e011cba3127
Public Version Date
February 16, 2022
Public Version Number
2
DI Record Publish Date
April 30, 2020
Package DI Number
20845357043102
Quantity per Package
2
Contains DI Package
10845357043105
Package Discontinue Date
March 31, 2021
Package Status
Not in Commercial Distribution
Package Type
2 Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1104 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |