| MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) (K193358) | Beckman Coulter, Inc. | 2020-03-03 |
| LIAISON Anti-HAV Assay (K193532) | DiaSorin, Inc. | 2020-03-02 |
| VITROS BRAHMS PCT Reagent Pack and Calibrators (K200236) | Ortho Clinical Diagnostics | 2020-02-25 |
| CareStart Flu A&B Plus (K191514) | Access Bio, Inc. | 2020-02-18 |
| VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) (K193567) | bioMerieux, Inc. | 2020-02-14 |
| cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System (K200065) | Roche Molecular Systems, Inc. | 2020-02-10 |
| BreathID Smart System (K193610) | Exalenz Bioscience , Ltd. | 2020-02-06 |
| LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set (K193051) | DiaSorin, Inc. | 2020-01-29 |
| HardyDisk AST Cefiderocol 30ug (FDC30) (K193504) | Hardy Diagnostics | 2020-01-23 |
| Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL (K193024) | Thermo Fisher Scientific | 2020-01-08 |
| BioCode Respiratory Pathogen Panel (RPP) (K192485) | Applied BioCode, Inc. | 2019-12-23 |
| Unyvero LRT BAL Application (K191967) | Curetis GmbH | 2019-12-20 |
| NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167) | Luminex Molecular Diagnostics, Inc. | 2019-12-11 |
| cobas vivoDx MRSA (DEN190016) | Roche Molecular Systems, Inc. | 2019-12-05 |
| WOUNDCHEK Bacterial Status (DEN180014) | Alere Scarborough, Inc. | 2019-12-02 |
| Access PCT, Access PCT Calibrators (K192271) | Beckman Coulter, Inc. | 2019-11-26 |
| ETEST Delafloxacin (DFX) (0.002-32 µg/mL) (K192738) | Biomerieux S.A. | 2019-11-26 |
| Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (K192376) | Diasorin Molecular, LLC | 2019-11-26 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) (K192355) | Beckman Coulter, Inc. | 2019-11-14 |
| xTAG Gastrointestinal Pathogen Panel (GPP) (K191161) | Luminex Molecular Diagnostics, Inc. | 2019-11-12 |
| B. anthracis Real-time PCR Assay (K192871) | Centers for Disease Control and Prevention | 2019-11-07 |
| Thermo Scientific Sensititre ARIS HiQ System (K191918) | Thermo Fisher Scientific | 2019-11-06 |
| Thermo Scientific Sensititre ARIS HiQ System (K191914) | Thermo Fisher Scientific | 2019-11-06 |
| Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml (K192729) | Thermo Fisher Scientific | 2019-11-06 |
| xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K191160) | Luminex Molecular Diagnostics, Inc. | 2019-11-04 |
| Vitek Densichek (K192110) | bioMerieux, Inc. | 2019-10-31 |
| MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL (K192345) | Liofilchem s.r.l. | 2019-10-31 |
| LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (K192046) | DiaSorin, Inc. | 2019-10-28 |
| BD MAX Vaginal Panel (K191957) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019-10-21 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL (K192250) | Thermo Fisher Scientific | 2019-10-16 |
| OraQuick Ebola Rapid Antigen Test (DEN190025) | OraSure Technologies, Inc. | 2019-10-10 |
| Cepheid Xpert Respiratory Control Panel (K190086) | Microbiologics, Inc. | 2019-10-07 |
| NG-Test CARBA 5 (K191889) | Ng Biotech | 2019-10-02 |
| ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) (K192050) | Biomerieux S.A. | 2019-09-27 |
| ARIES MRSA Assay (K191742) | Luminex Corporation | 2019-09-25 |
| HardyDisk AST Lefamulin 20µg (LMU20) (K192326) | Hardy Diagnostics | 2019-09-19 |
| MTS Imipenem 0.016-256 µg/mL (K191908) | Liofilchem s.r.l. | 2019-09-04 |
| BD MAX Check-Points CPO (K190613) | Check-Points Health B.V. | 2019-08-29 |
| MTS Imipenem-relebactam 0.002/4-32/4 µg/mL (K191809) | Liofilchem s.r.l. | 2019-08-23 |
| ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) (K191953) | Biomerieux S.A. | 2019-08-22 |
| Elecsys Anti-HAV II (K190428) | Roche Diagnostics | 2019-08-13 |
| binx health io CT/NG Assay (K191352) | Binx Health, Inc. | 2019-08-08 |
| VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) (K191766) | bioMerieux, Inc. | 2019-08-05 |
| HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) (K191931) | Hardy Diagnostics | 2019-07-31 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System (K190907) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System (K191398) | Zeus Scientific, Inc. | 2019-07-29 |
| ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System (K191240) | Zeus Scientific, Inc. | 2019-07-29 |
| Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729) | Roche Molecular Systems, Inc. | 2019-07-24 |
| Fungitell STAT (K191167) | Associates of Cape Cod, Inc. | 2019-07-17 |
| ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control (K191578) | Siemens Healthcare Diagnostics, Inc. | 2019-07-17 |
| ID NOW Influenza A & B 2 (K191534) | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 |
| BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) (K190905) | Becton, Dickinson and Company | 2019-07-01 |
| iC-GN iC-Cassette for use on the iC-System (K190341) | Icubate, Inc. | 2019-06-28 |
| Cepheid Xpert SA Nasal Complete Control Panel (K191168) | Microbiologics, Inc. | 2019-06-25 |
| Campylobacter Chek (K191442) | Techlab, Inc. | 2019-06-20 |
| Cepheid Xpert MRSA NxG Control Panel (K191172) | Microbiologics, Inc. | 2019-06-20 |
| Campylobacter Quik Chek (K191456) | Techlab, Inc. | 2019-06-20 |
| EntericBio Dx Assay (K182703) | Serosep , Ltd. | 2019-06-19 |
| SeraQuest HSV Type 2 Specific IgG (K181514) | Quest International, Inc. | 2019-06-13 |
| VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) (K190616) | bioMerieux, Inc. | 2019-06-06 |
| Biocode Gastrointestinal Pathogen Panel (GPP) (K190585) | Applied BioCode, Inc. | 2019-06-05 |
| MTS Doxycycline 0.016 - 256 µg/mL (K190914) | Liofilchem s.r.l. | 2019-05-29 |
| Aptima BV Assay (K190452) | Hologic, Inc. | 2019-05-23 |
| Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit (K190441) | Cepheid | 2019-05-23 |
| Aptima Combo 2 Assay (Panther System) (K190515) | Hologic, Inc. | 2019-05-23 |
| Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (DEN180032) | Cd Diagnostics, Inc. | 2019-05-23 |
| ZIKV Detect 2.0 IgM Capture ELISA (DEN180069) | InBios International, Inc. | 2019-05-23 |
| cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit (K190433) | Roche Molecular Systems, Inc. | 2019-05-22 |
| QIAstat-Dx Respiratory Panel (K183597) | QIAGEN GmbH | 2019-05-18 |
| Aptima CV/TV Assay (K190472) | Hologic, Inc. | 2019-05-16 |
| APAS Independence with Urine Analysis Module (K183648) | Clever Culture Systems AG | 2019-05-15 |
| BACT/ALERT MP Reagent System (K190405) | bioMerieux, Inc. | 2019-05-15 |
| Simplexa VZV Direct, Simplexa VZV Positive Control Pack (K190219) | Diasorin Molecular, LLC | 2019-05-13 |
| GenePOC Carba (K190275) | Genepoc, Inc. | 2019-05-10 |
| 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 |
| ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) (K190154) | Biomerieux S.A. | 2019-05-01 |
| HardyCHROM CRE (K190553) | Hardy Diagnostics | 2019-04-29 |
| Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K190771) | Cepheid | 2019-04-25 |
| FluChip-8G Influenza A+B Assay (K182513) | Indevr, Inc. | 2019-04-22 |
| Cepheid Xpert C. difficile/Epi Control Panel (K190463) | Microbiologics, Inc. | 2019-04-19 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) (K190109) | Beckman Coulter, Inc. | 2019-04-18 |
| ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K182619) | Genmark Diagnostics, Incorporated | 2019-04-12 |
| 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 B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit (K190302) | Centers for Disease Control and Prevention | 2019-03-27 |
| MTS Gentamicin 0.016 - 256 µg/mL (K190252) | Liofilchem s.r.l. | 2019-03-22 |
| MTS Ciprofloxacin 0.002 - 32 µg/mL (K183527) | Liofilchem s.r.l. | 2019-03-19 |
| Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (K181599) | Beckman Coulter | 2019-03-18 |
| ID NOW Influenza A & B 2 (K190204) | Alere Scarborough, Inc. | 2019-03-18 |
| Vstrip H. pylori Antigen Rapid Test (K183573) | Panion & BF Biotech, Inc. | 2019-03-14 |
| BioPlex 2200 Lyme Total (K183446) | Bio-Rad Laboratories | 2019-03-12 |
| Endotoxin Activity Assay (EAA) (K183176) | Spectral Medical, Inc. | 2019-03-12 |
| VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) (K183524) | bioMerieux, Inc. | 2019-03-12 |
| VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) (K183551) | bioMerieux, Inc. | 2019-03-07 |
| GenePOC Strep A (K183366) | Genepoc, Inc. | 2019-03-06 |
| VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL) (K183360) | bioMerieux, Inc. | 2019-02-26 |
| VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) (K183415) | bioMerieux, Inc. | 2019-02-20 |
| Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL (K183324) | Thermo Fisher Scientific | 2019-02-15 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) (K183127) | Beckman Coulter, Inc. | 2019-02-12 |
| BacT/ALERT FA Plus; BacT/ALERT PF Plus (K183166) | bioMerieux, Inc. | 2019-02-11 |
| Capture-CMV (K183571) | Immucor, Inc. | 2019-02-04 |