Duns Number:005460723
Device Description: iSWAB-Discovery Human DNA Collection Tube 400 ul
Catalog Number
ISF-T-DSC
Brand Name
Mawi DNA Technologies
Version/Model Number
ISF-T-DSC
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
NNL
Product Code Name
Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile
Public Device Record Key
e32043db-409c-44a4-a78b-f9fe3ce3b7e5
Public Version Date
April 14, 2022
Public Version Number
1
DI Record Publish Date
April 06, 2022
Package DI Number
10850040712077
Quantity per Package
50
Contains DI Package
00850040712070
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Rack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |