Duns Number:878263359
Device Description: Sequencing Consumables Kit
Catalog Number
4J94-92
Brand Name
ViroSeq
Version/Model Number
4J94-92
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
PPM
Product Code Name
General purpose reagent
Public Device Record Key
6fe93742-709b-4d2c-b524-82c565d520ca
Public Version Date
May 03, 2019
Public Version Number
3
DI Record Publish Date
February 20, 2017
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 | 339 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |
3 | A medical device with high risk that requires premarket approval | 36 |