Duns Number:033305264
Device Description: The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consu The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles.
Catalog Number
20028870
Brand Name
NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)
Version/Model Number
20028870
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
cd57fb4b-787d-479b-924c-e48450391f47
Public Version Date
July 30, 2021
Public Version Number
2
DI Record Publish Date
April 15, 2019
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 |