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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
Amplichek — BIO-RAD LABORATORIES, INC.Aptima® — Hologic, Inc.Amplichek — BIO-RAD LABORATORIES, INC.DASH® Negative Control Swabs Kit — Nuclein, LLCAmplichek — BIO-RAD LABORATORIES, INC.FilmArray GI Control Panel M238 — MmqciQC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.SPOTFIRE RSP Negative Control — MmqciAptima® — Hologic, Inc.NATtrol™ — ZEPTOMETRIX CORPORATIONQC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.Amplichek — BIO-RAD LABORATORIES, INC.FilmArray Warrior Control Panel M290 — MmqciBIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane — BIOFIRE DEFENSE, LLCAmplichek — BIO-RAD LABORATORIES, INC.Amplichek — BIO-RAD LABORATORIES, INC.FilmArray Pneumonia/Pneumoniaplus Control — MmqciAmplichek — BIO-RAD LABORATORIES, INC.NATtrol™ — ZEPTOMETRIX CORPORATIONSPOTFIRE RSP Positive Control — MmqciNATtrol™ — ZEPTOMETRIX CORPORATIONSavanna — DIAGNOSTIC HYBRIDS, INC.Savanna — DIAGNOSTIC HYBRIDS, INC.FilmArray RP2/RP2plus Control Panel — Mmqci
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-16 | Microbiologics Inc | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. |
| 2019-04-09 | Microbiologics Inc | Product with incorrect shelf life. |
| 2019-04-09 | Microbiologics Inc | Product with incorrect shelf life. |
| 2019-01-31 | Microbiologics Inc | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months. |
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