FDA UDI In Commercial Distribution 🇺🇸 United States

NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles)

DI: 00816270020569 · Model: 20046933 · ILLUMINA, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles)
Primary DI
00816270020569
Version / Model
20046933
Catalog Number
20046933
Company Name
ILLUMINA, INC.
Labeler DUNS
033305264
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-18
Public Version
1
Public Version Date
2022-10-26
Public Version Status
New
Public Device Record Key
196581f4-2826-4d35-b521-27024003f9fb

Device Description

The NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) is single-use sets of reagents and consumables for sequencing on the NovaSeq 6000Dx Instrument. The NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) use libraries generated using validated assays. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible terminator method to detect fluorescently labeled single nucleotide bases as they are incorporated into growing DNA strands. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20046938, NovaSeq™ 6000Dx S4 Cluster Cartridge; 20046940, NovaSeq™ 6000Dx S4 SBS Cartridge; and 20045448, NovaSeq™ 6000Dx S4 Flow Cell.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
62173 Nucleic acid sequencing reagent kit IVD

Identifiers

Type ID
Primary 00816270020569

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
15 – 30 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
-25 – -15 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius