Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

DEN150058 is the FDA 510(k) clearance record for Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak, a class II device, cleared for Bio-Rad Laboratories on 2016-03-28 under FDA product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays). FDA's definition for product code PMN reads: "Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use". FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from 1991-07-25 to 2019-03-12. As of 2026-09-10, FDA records show no recalls naming DEN150058.