Assayed external control material for microbiology nucleic acid amplification (NAT) assays
FDA product code PMN · Class 2 · 4 devices · 1 reports · 3 devices named in recalls
- QC Sets and Panels: Helix Elite™ 8193 BD MAX™ CT/GC/TV 20-Day QC PanelMicrobiologics Inc. · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays1 recall0 reports
- QC Sets and Panels: Helix Elite™ 8199 Cepheid Xpert® Respiratory Control PanelMicrobiologics Inc. · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays1 recall0 reports
- QC Sets and Panels: Helix Elite™ 8200 Cepheid Xpert® C. difficile/Epi Control PanelMicrobiologics Inc. · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays1 recall0 reports
- Aptima® KIT, BOX 1, REFRIGERATED, ABV, 100T, IVDHologic, Inc. · Assayed external control material for microbiology nucleic acid amplification (NAT) assays1 report