Home › Device types › PFT
Reagents For Molecular Diagnostic Test Systems
FDA product code PFT · Class 1 · Clinical Chemistry
57
Registered devices
0
Adverse events
2
Recalls
1
510(k) clearances
Devices with this code
TruSight™ Cystic Fibrosis Library Preparation — ILLUMINA, INC.DynaMag™ 16-2mL Tube Dx — LIFE TECHNOLOGIES CORPORATIONNovaSeq™ 6000Dx S2 Buffer Cartridge — ILLUMINA, INC.MagMAX™ Viral/Pathogen Wash Solution — THERMO FISHER SCIENTIFIC BALTICS UABSentosa SQ Sequencing Solutions (8) — VELA OPERATIONS SINGAPORE PTE. LTD.NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) — ILLUMINA, INC.Sentosa SQ Sequencing Reagents (8) — VELA OPERATIONS SINGAPORE PTE. LTD.DynaMag™ 96-Well Plate Dx, 5-200 uL — LIFE TECHNOLOGIES CORPORATIONIon OneTouch™ Dx Template ES Beads — LIFE TECHNOLOGIES CORPORATIONIon PGM™ Dx Library Equalizer — LIFE TECHNOLOGIES CORPORATIONIllumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples) — ILLUMINA, INC.NovaSeq™ 6000Dx Library Tube, 24 pack — ILLUMINA, INC.Ion OneTouch™ Dx Sequencing Reagents — LIFE TECHNOLOGIES CORPORATIONSentosa ST Template Beads (8) — VELA OPERATIONS SINGAPORE PTE. LTD.InviTrap Spin Universal RNA Kit (250) — Invitek Molecular GmbHSentosa SX IA Reactions Kit (4) — VELA OPERATIONS SINGAPORE PTE. LTD.PSP SalivaGene DNA Kit (250) — Invitek Molecular GmbHNextSeq550Dx Reagent Kit v2(300 cyc) IVD — ILLUMINA, INC.TruSeq Custom Amplicon Kit Dx - FFPE QC — ILLUMINA, INC.PSP Spin Stool DNA Basic Kit (250) — Invitek Molecular GmbHPSP Spin Stool DNA Basic Kit (50) — Invitek Molecular GmbHMagMAX™ Viral/Pathogen Elution Buffer — THERMO FISHER SCIENTIFIC BALTICS UABIon OneTouch™ Dx Template Supplies — LIFE TECHNOLOGIES CORPORATIONIon PGM™ Dx Sequencing Supplies — LIFE TECHNOLOGIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-28 | Illumina, 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 t |
| 2018-04-26 | Horiba Instruments, Inc dba Horiba Medical | When 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, |
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