Duns Number:929236305
Device Description: Microbrush Anterior Nares Mid-Turbinate Test Swabs
Catalog Number
292512
Brand Name
Microbrush
Version/Model Number
292512
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
QQX
Product Code Name
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Public Device Record Key
a0a2d466-ba86-459a-b434-acd1ab9ec238
Public Version Date
October 05, 2022
Public Version Number
4
DI Record Publish Date
August 16, 2022
Package DI Number
10789594001101
Quantity per Package
100
Contains DI Package
00789594001104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Package
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 43 |