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NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles)

ILLUMINA, INC. · Model 20028871 · UDI-DI 00816270020118

PFT Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
13
Facilities

Description

The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is a single-use set of reagents and consumables for sequencing on the NextSeq™ 550Dx instrument. For its input, the NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) uses libraries generated from DNA where sample indexes and capture sequences are added to amplified 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 fluorescently-labeled single nucleotide bases as they are incorporated into growing DNA strands. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) is an IVD kit consisting of the individual boxes listed below, which are all labeled with the same Device Identifier: 20019555, NextSeq™ 550Dx High Output Reagent Cartridge v2, 300 cycles; 20019556, NextSeq™ 550Dx Buffer Cartridge v2, 300 cycles; 20026365, NextSeq™ 550Dx High Output Flow Cell Cartridge v2.5, 300 cycles; 20019558, NextSeq™ 550Dx Accessory Box – 300 cycles.

Recalls

DateFirmReason
2025-10-28Illumina, Inc.An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality i
2018-04-26Horiba Instruments, Inc dba Horiba MedicalWhen the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.