| ARCHITECT Toxo IgG (K210596) | Abbott Laboratories | 2022-05-19 |
| BD CTGCTV2 (K210585) | Becton, Dickinson and Company | 2022-05-10 |
| Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (K203429) | Cepheid | 2022-05-09 |
| BioTeke Sterile Disposable Virus Sampling Kit (K211707) | Bioteke Corporation (Wuxi) Co., Ltd. | 2022-05-04 |
| BioFire Joint Infection (JI) Panel (DEN200066) | Biofire Diagnostics, LLC | 2022-04-29 |
| Alinity m STI Assay (K202977) | Abbott Molecular, Inc. | 2022-04-29 |
| ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K213236) | Genmark Diagnostics, Incorporated | 2022-04-27 |
| VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) (K214023) | bioMerieux, Inc. | 2022-04-14 |
| Healgen Strep A Rapid Test Strip (Throat Swab) (K212623) | Healgen Scientific,, LLC | 2022-03-16 |
| VITEK MS PRIME (K212461) | bioMerieux, Inc. | 2022-03-15 |
| VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (K213241) | bioMerieux, Inc. | 2022-02-25 |
| Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System (K212213) | Cepheid | 2022-02-09 |
| VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) (K212849) | Biomérieux, Inc. | 2022-02-04 |
| NATtrol BD MAX Vaginal Panel External Controls (K201403) | Zeptometrix | 2022-02-02 |
| MDx-Chex for BCID2 (K212576) | Streck, Inc. | 2022-01-19 |
| Colibri System (K193138) | Copan Wasp Srl | 2021-12-27 |
| Curian Campy (K210976) | Meridian Bioscience, Inc. | 2021-12-23 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml (K203741) | Thermo Fisher Scientific | 2021-12-20 |
| Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit (K193081) | Rheonix, Inc. | 2021-12-17 |
| Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL (K211539) | Thermo Fisher Scientific | 2021-12-15 |
| SeptiCyte RAPID (K203748) | Immunexpress, Inc. | 2021-11-29 |
| Sofia 2 Campylobacter FIA (K211342) | Quidel Corporation | 2021-11-23 |
| ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757) | Biomerieux S.A. | 2021-11-12 |
| BD Kiestra IdentifA (K191964) | Becton, Dickinson and Company | 2021-11-03 |
| OMNIgene GUT Dx (DEN200040) | DNA Genotek, Inc. | 2021-11-03 |
| BioFire COVID-19 Test 2 (K211079) | Biofire Defense, LLC | 2021-11-01 |
| APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839) | Clever Culture Systems | 2021-10-28 |
| VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) (K210287) | bioMerieux, Inc. | 2021-10-28 |
| Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (K210873) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-10-27 |
| InTray GC (K210511) | Biomed Diagnostics Incorporated | 2021-10-20 |
| MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL (K211672) | Liofilchem s.r.l. | 2021-10-20 |
| cobas Cdiff nucleic acid test for use on the cobas Liat System (K212427) | Roche Molecular Systems, Inc. | 2021-10-20 |
| BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit (K201017) | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021-10-18 |
| Acuitas AMR Gene Panel (K191288) | Opgen, Inc. | 2021-09-30 |
| FilmArray Pneumonia Panel (K212727) | Biofire Diagnostics, LLC | 2021-09-22 |
| Disposable Sampler Inactivated Transport Media, Nest ITM (K210440) | Wuxi Nest Biotechnology Co., Ltd. | 2021-09-20 |
| VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) (K202396) | bioMerieux, Inc. | 2021-09-14 |
| cobas Cdiff nucleic acid test for use on the cobas Liat System (K210385) | Roche Molecular Systems, Inc. | 2021-09-09 |
| MeMed BV (K210254) | MeMed Diagnostics, Ltd. | 2021-09-01 |
| VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) (K211630) | bioMerieux, Inc. | 2021-08-30 |
| Visby Medical Sexual Health (K200748) | Visby Medical | 2021-08-26 |
| Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (K212204) | Cd Diagnostics, Inc. | 2021-08-11 |
| Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 (K203700) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2021-07-30 |
| Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) (K202612) | Thermo Fisher Scientific | 2021-07-23 |
| Elecsys Syphilis (K211302) | Roche Diagnostics | 2021-07-20 |
| VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) (K201675) | bioMerieux, Inc. | 2021-07-09 |
| SensiTox C. difficile Toxin Test (K193490) | First Light Diagnostics, Inc. | 2021-07-08 |
| BioFire RP2.1/RP2.1plus Control Panel M441 (K202196) | Maine Molecular Quality Controls, Inc. | 2021-06-24 |
| VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) (K211136) | bioMerieux, Inc. | 2021-06-14 |
| MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) (K202423) | Beckman Coulter, Inc. | 2021-05-18 |
| Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K203295) | Gold Standard Diagnostics | 2021-03-22 |
| Capture-CMV (K203612) | Immucor, Inc. | 2021-03-22 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K203292) | Gold Standard Diagnostics | 2021-03-22 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K203296) | Gold Standard Diagnostics | 2021-03-22 |
| Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (K203289) | Gold Standard Diagnostics | 2021-03-22 |
| BioFire Respiratory Panel 2.1 (RP2.1) (DEN200031) | Biofire Diagnostics, LLC | 2021-03-17 |
| Cultura Collection and Transport System (K201674) | Merit Medical Systems, Inc. | 2021-03-03 |
| LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (K202573) | DiaSorin, Inc. | 2021-02-18 |
| LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (K202574) | DiaSorin, Inc. | 2021-02-18 |
| cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (K210234) | Roche Molecular Systems, Inc. | 2021-02-16 |
| LIAISON Anti-HAV (K210272) | DiaSorin, Inc. | 2021-02-09 |
| cobas BKV (K203220) | Roche Molecular Systems, Inc. | 2021-01-29 |
| cobas CTNG for use on cobas 6800/8800 systems (K202408) | Roche Molecular Systems, Inc. | 2021-01-21 |
| MBT Sepsityper (K193419) | Bruker Daltonik GmbH | 2020-12-27 |
| DNA/RNA Shield Collection Tube (K202641) | Zymo Research | 2020-12-14 |
| Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 (K193508) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2020-12-04 |
| FilmArray Global Fever Panel (DEN200043) | Biofire Defense, LLC | 2020-11-20 |
| FilmArray Global Fever Panel External Control Kit (K202382) | Biofire Defense, LLC | 2020-11-20 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) (K202343) | Beckman Coulter, Inc. | 2020-11-16 |
| Accula Strep A Test (K201269) | Mesa Biotech, Inc. | 2020-11-09 |
| ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer (K201438) | Arlington Scientific, Inc. (Asi) | 2020-10-21 |
| VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) (K193299) | bioMerieux, Inc. | 2020-09-28 |
| eNAT molecular collection and preservation medium (K201849) | Copan Italia Spa | 2020-09-17 |
| Accelerate Pheno System, Accelerate PhenoTest BC Kit (K192665) | Accelerate Diagnostics, Inc. | 2020-09-15 |
| cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (K202215) | Roche Molecular Systems, Inc. | 2020-09-02 |
| LabPro Data Management System (K201405) | Beckman Coulter, Inc. | 2020-08-30 |
| Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (K201505) | Diasorin Molecular, LLC | 2020-08-22 |
| cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (DEN200015) | Roche Molecular Systems, Inc. | 2020-07-30 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K201423) | Beckman Coulter, Inc. | 2020-06-29 |
| DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) | Chembio Diagnostic Systems | 2020-06-03 |
| Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) (K200866) | Hologic, Inc. | 2020-05-17 |
| NP Screen (DEN190031) | Advance Sentry Corporation | 2020-05-11 |
| ETEST Plazomicin (PLZ) (0.016-256 µg/mL) (K200512) | Biomérieux SA | 2020-05-07 |
| VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) (K200590) | bioMerieux, Inc. | 2020-04-28 |
| binx io CT/NG Assay and binx io CT/NG System (K200533) | Binx Health, Inc. | 2020-04-27 |
| Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K200023) | Gold Standard Diagnostics | 2020-04-06 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K200025) | Gold Standard Diagnostics | 2020-04-06 |
| MTS Lefamulin 0.016- 256 µg/mL (K200308) | Liofilchem S. R. 1. | 2020-04-06 |
| Osom Ultra Plus Flu A&B Test Kit (K192719) | SEKISUI Diagnostics, LLC | 2020-04-03 |
| FilmArray BCID2 Control Panel M416 (K200010) | Maine Molecular Quality Controls, Inc. | 2020-04-02 |
| Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit (K200436) | Hologic, Inc. | 2020-03-23 |
| MTS Omadacycline 0.002 - 32 ug/mL (K200180) | Liofilchem s.r.l. | 2020-03-20 |
| BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) | Biofire Diagnostics, LLC | 2020-03-18 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) (K193536) | Beckman Coulter, Inc. | 2020-03-18 |
| VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) (K193572) | bioMerieux, Inc. | 2020-03-13 |
| Curian HpSA, Curian Analyzer (K192817) | Meridian Bioscience, Inc. | 2020-03-13 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml (K193538) | Thermo Fisher Scientific | 2020-03-12 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit (K200370) | Centers for Disease Control and Prevention | 2020-03-10 |
| Elecsys BRAHMS PCT (K192815) | Roche Diagnostics | 2020-03-09 |
| ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (K191184) | Ssi Diagnostica A/S | 2020-03-05 |