| BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (K261475) | Biofire Defense, LLC | 2026-07-17 |
| FilmArray TF Control Panel M527 (K260577) | Maine Molecular Quality Controls, Inc. | 2026-05-19 |
| MDx-Chex for BCP (K260041) | Streck, LLC | 2026-03-27 |
| MDx-Chex for BCN (K254166) | Streck | 2026-03-23 |
| MDx-Chex for BCY (K254167) | Streck, LLC | 2026-03-17 |
| FilmArray GI Control Panel M238 (K251526) | Maine Molecular Quality Controls, Inc. | 2025-08-14 |
| SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (K241289) | Maine Molecular Quality Controls, Inc. | 2024-05-30 |
| SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (K233611) | Maine Molecular Quality Controls, Inc. | 2024-03-26 |
| MDx-Chex for BC-GP (K231221) | Streck | 2023-07-27 |
| MDx-Chex for BC-GN (K231223) | Streck | 2023-07-27 |
| SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (K230868) | Maine Molecular Quality Controls, Inc. | 2023-04-13 |
| SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253) | Maine Molecular Quality Controls, Inc. | 2023-02-03 |
| BioFire JI Control Panel M420 (K203680) | Maine Molecular Quality Controls, Inc. | 2022-07-22 |
| NATtrol BD MAX Vaginal Panel External Controls (K201403) | Zeptometrix | 2022-02-02 |
| MDx-Chex for BCID2 (K212576) | Streck, Inc. | 2022-01-19 |
| BioFire RP2.1/RP2.1plus Control Panel M441 (K202196) | Maine Molecular Quality Controls, Inc. | 2021-06-24 |
| FilmArray Global Fever Panel External Control Kit (K202382) | Biofire Defense, LLC | 2020-11-20 |
| FilmArray BCID2 Control Panel M416 (K200010) | Maine Molecular Quality Controls, Inc. | 2020-04-02 |
| Cepheid Xpert Respiratory Control Panel (K190086) | Microbiologics, Inc. | 2019-10-07 |
| Cepheid Xpert SA Nasal Complete Control Panel (K191168) | Microbiologics, Inc. | 2019-06-25 |
| Cepheid Xpert MRSA NxG Control Panel (K191172) | Microbiologics, Inc. | 2019-06-20 |
| Cepheid Xpert CT/NG Control Panel (K190223) | Microbiologics, Inc. | 2019-05-08 |
| FilmArray Pneumonia/Pneumoniaplus Control (K190222) | Maine Molecular Quality Controls, Inc. | 2019-05-03 |
| Cepheid Xpert C. difficile/Epi Control Panel (K190463) | Microbiologics, Inc. | 2019-04-19 |
| Cepheid Xpert GBS LB Control Panel (K182472) | Microbiologics, Inc. | 2018-11-08 |
| BD MAX CT/GC/TV 20-Day QC Panel (K181683) | Microbiologics, Inc. | 2018-08-28 |
| BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel (K181711) | Microbiologics, Inc. | 2018-08-15 |
| FilmArray RP2/RP2plus Control Panel (K173171) | Maine Molecular Quality Controls, Inc. | 2017-11-24 |
| FilmArray Warrior Control Panel M290 (K163522) | Maine Molecular Quality Controls, Inc. | 2017-03-14 |
| FilmArray RP EZ Control Panel M265 (K161573) | Maine Molecular Quality Controls, Inc. | 2016-09-02 |
| Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak (K152679) | Bio-Rad Laboratories | 2016-05-10 |
| 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 | 2016-03-28 |