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NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles)
EUDAMEDFDA UDIClass A (EU MDR)
Ref 20046933
Identity
- Trade Name
- NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- NovaSeq™ 6000Dx Reagent v1.5 Kit (300 cycles) EUDAMEDThe 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. FDA UDI
- Model / Reference
- 20046933 EUDAMEDFDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 20046933 FDA UDI
- Primary DI / UDI-DI
- 00816270020569 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081627002NSQKTTN EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid sequencing reagent kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMED
- 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 S4 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0081627002NSQKTTN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Illumina, Inc.
- EUDAMED SRN
- US-MF-000013476
- Authorised Representative
- Illumina Netherlands B.V. NL-AR-000012614
Sources (2)
- EUDAMED 0b0266ad-e1dc-49ce-8787-771cd1198f23 61 fields · synced Jul 10, 2026
- FDA UDI 196581f4-2826-4d35-b521-27024003f9fb 35 fields · synced May 30, 2026