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MiSeq™Dx Reagent Kit v3

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 20037124

by Illumina, Inc.

Identity

Trade Name
MiSeq™Dx Reagent Kit v3 EUDAMED
MiSeq™ Dx Reagent Kit v3 FDA UDI
Generic Name
Nucleic acid sequencing reagent kit IVD FDA UDI
Device Name
MiSeq™Dx Reagent Kit EUDAMED
The MiSeq™ Dx Reagent Kit v3 uses libraries prepared from DNA where sample indexes and capture sequences are added to targets. 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 single nucleotide bases as they are incorporated into growing DNA strands. The Illumina MiSeq™ Dx Reagent Kit v3 is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeq™ Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The MiSeq™ Dx Reagent Kit v3 is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20036261, MiSeqDx Reagent Kit v3, 1/2; 20036262, MiSeqDx Reagent Kit v3, 2/2 FDA UDI
Model / Reference
20037124 EUDAMEDFDA UDI
Description
The MiSeq™ Dx Reagent Kit v3 uses libraries prepared from DNA where sample indexes and capture sequences are added to targets. 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 single nucleotide bases as they are incorporated into growing DNA strands. The Illumina MiSeq™ Dx Reagent Kit v3 is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeq™ Dx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The MiSeq™ Dx Reagent Kit v3 is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20036261, MiSeqDx Reagent Kit v3, 1/2; 20036262, MiSeqDx Reagent Kit v3, 2/2 FDA UDI

Identifiers

Catalog Number
20037124 FDA UDI
Primary DI / UDI-DI
00816270020156 EUDAMEDFDA UDI
Basic UDI-DI
0081627002KITV3PX 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

No

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

MiSeq™Dx Reagent Kit v3 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

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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 426628ea-a27f-4996-a052-c77c5f89e43b 61 fields · synced Jul 20, 2026
  • FDA UDI 73b003ba-52c8-4b4c-a85d-b727984f6c38 35 fields · synced May 30, 2026