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device 510k
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Biofire Defense, LLC — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (510k cleared)

March 12, 2025updated 5mo ago
community read0 votes

Product code: PRD. Advisory committee: Immunology. Type: Traditional

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fda device 510k
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same company · ±60 days · 4

  • device 510kKamiya Biomedical Company, LLC — K-ASSAY CRP (Ver.2) (510k cleared)Apr 18, 2025
  • device 510kHycor Biomedical — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz (510k cleared)Apr 23, 2025
  • device 510kRoche Diagnostics Operations — Tina-quant Lipoprotein(a) Gen.2 Molarity (510k cleared)Jan 24, 2025
  • device 510kZeus Scientific — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (510k cleared)May 7, 2025

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