Duns Number:956711444
Device Description: Swab Specimen Collection Kit
Catalog Number
SWAB/G-50-US
Brand Name
Xpert®
Version/Model Number
SWAB/G-50-US
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
-
Product Code
PQA
Product Code Name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Public Device Record Key
1c54ddc0-3b11-4682-bd7b-6312120bca2e
Public Version Date
August 19, 2022
Public Version Number
2
DI Record Publish Date
April 12, 2022
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 | 53 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 78 |