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Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA product code PMN · Class 2 · Microbiology

53
Registered devices
1
Adverse events
4
Recalls
32
510(k) clearances

Devices with this code

Aptima® — Hologic, Inc.Aptima® — Hologic, Inc.QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.NATtrol™ — ZEPTOMETRIX CORPORATIONQC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.Amplichek — BIO-RAD LABORATORIES, INC.FilmArray Warrior Control Panel M290 — MmqciAmplichek — BIO-RAD LABORATORIES, INC.BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane — BIOFIRE DEFENSE, LLCQC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.Amplichek — BIO-RAD LABORATORIES, INC.FilmArray GI Control Panel M238 — MmqciFilmArray Pneumonia/Pneumoniaplus Control — MmqciMDx-Chex for BC-GN — STRECK, INC.Amplichek — BIO-RAD LABORATORIES, INC.Amplichek — BIO-RAD LABORATORIES, INC.QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.BioFire Warrior Panel Control Kit — BIOFIRE DEFENSE, LLCAptima® — Hologic, Inc.DASH® Negative Control Swabs Kit — Nuclein, LLCAptima® — Hologic, Inc.QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.Amplichek — BIO-RAD LABORATORIES, INC.Amplichek — BIO-RAD LABORATORIES, INC.

Recent recalls

DateFirmReason
2019-05-16Microbiologics IncProduct is labeled with expiration date of 2021-10-31, should be 2021-03-31.
2019-04-09Microbiologics IncProduct with incorrect shelf life.
2019-04-09Microbiologics IncProduct with incorrect shelf life.
2019-01-31Microbiologics IncCepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.