← Back to catalogue

NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 20046931

by Illumina, Inc.

Identity

Trade Name
NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles) EUDAMED
NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) FDA UDI
Generic Name
Nucleic acid sequencing reagent kit IVD FDA UDI
Device Name
NovaSeq™ 6000Dx Reagent v1.5 Kit (300 cycles) EUDAMED
The NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) is single-use sets of reagents and consumables for sequencing on the NovaSeq™ 6000Dx Instrument. The NovaSeq™ 6000Dx S2 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 S2 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: 20046934, NovaSeq™ 6000Dx S2 Cluster Cartridge; 20046936, NovaSeq™ 6000Dx S2 SBS Cartridge; and 20045447, NovaSeq™ 6000Dx S2 Flow Cell. FDA UDI
Model / Reference
20046931 EUDAMEDFDA UDI
Description
The NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) is single-use sets of reagents and consumables for sequencing on the NovaSeq™ 6000Dx Instrument. The NovaSeq™ 6000Dx S2 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 S2 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: 20046934, NovaSeq™ 6000Dx S2 Cluster Cartridge; 20046936, NovaSeq™ 6000Dx S2 SBS Cartridge; and 20045447, NovaSeq™ 6000Dx S2 Flow Cell. FDA UDI

Identifiers

Catalog Number
20046931 FDA UDI
Primary DI / UDI-DI
00816270020538 EUDAMEDFDA UDI
Basic UDI-DI
0081627002NSQKTTN EUDAMED
FDA Product Code
PFT FDA UDI
EMDN Code
W010699 GENETIC TESTS - OTHER EUDAMED
GMDN Term
Nucleic acid sequencing reagent kit IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
862.3800 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

Yes

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles) by Illumina, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Illumina, Inc.
EUDAMED SRN
US-MF-000013476
Authorised Representative
Illumina Netherlands B.V. NL-AR-000012614

Sources (2)

  • EUDAMED ee591c2a-16b2-428f-978b-fc3bf6949e05 61 fields · synced Jun 17, 2026
  • FDA UDI e4722c92-f35a-4f97-ad52-bcc036e80748 36 fields · synced May 30, 2026