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
InviTrap Spin Universal RNA Kit (250) — Invitek Molecular GmbHMagMAX™ MVP II BINDING BEADS — THERMO FISHER SCIENTIFIC BALTICS UABNovaSeq™ 6000Dx Library Tube — ILLUMINA, INC.MiSeqDx Universal Kit 1.0 — ILLUMINA, INC.PGDx elio™ diversiPhi — PERSONAL GENOME DIAGNOSTICS INC.MiSeqDx Reagent Kit v3 — ILLUMINA, INC.NovaSeq™ 6000Dx S2 Buffer Cartridge — ILLUMINA, INC.InviTrap Spin Universal RNA Kit (50) — Invitek Molecular GmbHIllumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples) — ILLUMINA, INC.Sentosa SX IA Reagents Kit (8) — VELA OPERATIONS SINGAPORE PTE. LTD.MagMAX™ Viral/Pathogen Elution Buffer — THERMO FISHER SCIENTIFIC BALTICS UABLocal Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx — ILLUMINA, INC.NovaSeq™ 6000Dx S4 Buffer Cartridge — ILLUMINA, INC.Sentosa ST Template Reagents (8) — VELA OPERATIONS SINGAPORE PTE. LTD.Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples) — ILLUMINA, INC.DynaMag™ 96-Well Plate Dx, 5-200 uL — LIFE TECHNOLOGIES CORPORATIONIllumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples) — ILLUMINA, INC.Sentosa SX IA Reactions Kit (4) — VELA OPERATIONS SINGAPORE PTE. LTD.MagMAX™ Viral/Pathogen Binding Solution — THERMO FISHER SCIENTIFIC BALTICS UABLocal Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx — ILLUMINA, INC.Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples) — ILLUMINA, INC.PSP Spin Stool DNA Basic Kit (50) — Invitek Molecular GmbHIon PGM™ Dx Library Reagents — LIFE TECHNOLOGIES CORPORATIONNextSeq550Dx Reagent Kit v2(300 cyc) IVD — ILLUMINA, INC.
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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