Duns Number:033305264
Device Description: The NovaSeq™ 6000Dx S4 Buffer Cartridge is a single-use set of buffers and wash solution p The NovaSeq™ 6000Dx S4 Buffer Cartridge is a single-use set of buffers and wash solution prefilled in the cartridge. The set is boxed together in one box, 20046947, NovaSeq™ 6000Dx S4 Buffer Cartridge, which is labeled with the same Device Identifier.
Catalog Number
20062293
Brand Name
NovaSeq™ 6000Dx S4 Buffer Cartridge
Version/Model Number
20062293
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
PFT
Product Code Name
Reagents For Molecular Diagnostic Test Systems
Public Device Record Key
da88919a-f68d-4a6d-b039-4cf04b2548cb
Public Version Date
October 26, 2022
Public Version Number
1
DI Record Publish Date
October 18, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| 3 | A medical device with high risk that requires premarket approval | 1 |