PMN · Class II · 21 CFR 866.3920

FDA Product Code PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.

Leading manufacturers include Maine Molecular Quality Controls, Inc., Microbiologics, Inc. and Streck.

32
Total
31
Cleared
135d
Avg days
2016
Since
32 devices
25–32 of 32
Cleared Nov 08, 2018
Cepheid Xpert GBS LB Control Panel
K182472
Microbiologics, Inc.
Microbiology · 59d
Cleared Aug 28, 2018
BD MAX CT/GC/TV 20-Day QC Panel
K181683
Microbiologics, Inc.
Microbiology · 63d
Cleared Aug 15, 2018
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
K181711
Microbiologics, Inc.
Microbiology · 48d
Cleared Nov 24, 2017
FilmArray RP2/RP2plus Control Panel
K173171
Maine Molecular Quality Controls, Inc.
Microbiology · 56d
Cleared Mar 14, 2017
FilmArray Warrior Control Panel M290
K163522
Maine Molecular Quality Controls, Inc.
Microbiology · 89d
Cleared Sep 02, 2016
FilmArray RP EZ Control Panel M265
K161573
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared May 10, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
K152679
Bio-Rad Laboratories
Microbiology · 235d
Not Cleared Mar 28, 2016
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
Bio-Rad Laboratories
Microbiology · 103d