| Aptima Mycoplasma genitalium Assay (DEN180047) | Hologic, Inc. | 2019-01-23 |
| HardyDisk AST Omadacycline 30µg (OMC30) (K183298) | Hardy Diagnostics | 2019-01-18 |
| ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (K183031) | Biomerieux S.A. | 2019-01-11 |
| MTS Tetracycline 0.016 - 256 ug/mL (K183140) | Liofilchem s.r.l. | 2019-01-11 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml (K183033) | Thermo Fisher Scientific | 2019-01-04 |
| VITEK MS (K181412) | bioMerieux, Inc. | 2018-12-21 |
| ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (K182690) | Genmark Diagnostics, Incorporated | 2018-12-21 |
| ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663) | Genmark Diagnostics, Incorporated | 2018-12-20 |
| MTS Levofloxacin 0.002 - 32 µg/mL (K183115) | Liofilchem s.r.l. | 2018-12-20 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K183223) | Diasorin Molecular, LLC | 2018-12-19 |
| Acucy Influenza A&B Test with the Acucy System (K182001) | SEKISUI Diagnostics, LLC | 2018-12-17 |
| MTS Omadacycline 0.002-32 µg/mL (K182922) | Liofilchem s.r.l. | 2018-12-14 |
| VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance (K181766) | bioMerieux, Inc. | 2018-12-10 |
| xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K183023) | Luminex Molecular Diagnostics, Inc. | 2018-11-30 |
| Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (DEN180040) | Meridian Bioscience, Inc. | 2018-11-30 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL (K182797) | Thermo Fisher Scientific | 2018-11-30 |
| xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K183030) | Luminex Molecular Diagnostics, Inc. | 2018-11-30 |
| ASI Automated ASI RPR Test for Syphilis on the ASI Evolution (K182391) | Arlington Scientific, Inc. (Asi) | 2018-11-30 |
| BD MAX Enteric Viral Panel, BD MAX Instrument (K181427) | Becton, Dickinson and Company | 2018-11-29 |
| Accula RSV Test (K181443) | Mesa Biotech, Inc. | 2018-11-23 |
| FilmArray Pneumonia Panel (K180966) | Biofire Diagnostics, LLC | 2018-11-09 |
| Cepheid Xpert GBS LB Control Panel (K182472) | Microbiologics, Inc. | 2018-11-08 |
| Simplexa GBS Direct, Simplexa GBS Positive Control Pack (K182467) | Diasorin Molecular, LLC | 2018-11-07 |
| PREMIER Platinum HpSA PLUS (K182559) | Meridian Bioscience, Inc. | 2018-11-05 |
| MTS Eravacycline 0.002 - 32 µg/mL (K182557) | Liofilchem s.r.l. | 2018-11-02 |
| HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (K180559) | Elitechgroup | 2018-10-29 |
| BioCode Gastrointestinal Pathogen Panel (GPP) (K180041) | Applied BioCode, Inc. | 2018-09-28 |
| Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 (K181975) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2018-09-27 |
| HardyDisk AST Eravacycline 20µg (ERV20) (K182357) | Hardy Diagnostics | 2018-09-26 |
| BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN (K181665) | Becton, Dickinson and Company | 2018-09-21 |
| NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET (DEN070001) | Centers for Disease Control and Prevention | 2018-09-21 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K181205) | Centers for Disease Control and Prevention | 2018-09-20 |
| BioSign Flu A+B (K182157) | Princeton BioMeditech Corp. | 2018-09-18 |
| MTS Penicillin 0.002- 32 µg/mL (K181889) | Liofilchem s.r.l. | 2018-09-13 |
| LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (K181464) | DiaSorin, Inc. | 2018-08-31 |
| Sofia 2 Lyme FIA, Sofia Lyme Control Set (K173496) | Quidel Corporation | 2018-08-30 |
| BD MAX CT/GC/TV 20-Day QC Panel (K181683) | Microbiologics, Inc. | 2018-08-28 |
| DENV Detect NS1 ELISA (K181473) | InBios International, Inc. | 2018-08-27 |
| ADVIA Centaur Herpes-1 IgG (K181333) | Biokit, S.A. | 2018-08-23 |
| ADVIA Centaur Herpes-2 IgG (K181334) | Biokit, S.A. | 2018-08-23 |
| H. PYLORI QUIK CHEK (K181379) | Techlab, Inc. | 2018-08-21 |
| H. PYLORI CHEK™ (K181400) | Techlab, Inc. | 2018-08-21 |
| Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System (K181289) | Cepheid | 2018-08-15 |
| BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel (K181711) | Microbiologics, Inc. | 2018-08-15 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K173498) | Diasorin Molecular, LLC | 2018-08-13 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader (K181853) | Alere Scarborough, Inc. | 2018-08-08 |
| Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL (K181946) | Thermo Fisher Scientific | 2018-08-08 |
| MTS Plazomicin 0.016-256 µg/mL (K181708) | Liofilchem s.r.l. | 2018-07-31 |
| CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, (K181736) | Centers For Disease Control and Prevention (CDC) | 2018-07-30 |
| ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (K181213) | Siemens Healthcare Diagnostics, Inc. | 2018-07-30 |
| Panther Fusion GBS Assay (K181156) | Diagenode | 2018-07-27 |
| Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K180218) | Cepheid | 2018-07-24 |
| Atellica IM BRAHMS Procalcitonin (PCT) (K181002) | Siemens Healthcare Diagnostics, Inc. | 2018-07-16 |
| Solana Bordetella Complete Assay (K181029) | Quidel Corporation | 2018-07-15 |
| HardyDisk AST Plazomicin 30ug (PLZ30) (K181700) | Hardy Diagnostics | 2018-07-10 |
| Elecsys BRAHMS PCT (K173927) | Roche Diagnostics | 2018-07-06 |
| CHROMID CARBA agar (CARB) (K181092) | Biomerieux S.A. | 2018-07-06 |
| FilmArray Blood Culture Identification (BCID) Panel (K181493) | Biofire Diagnostics, LLC | 2018-07-05 |
| ETEST Telavancin (TLA) (0.002-32 ug/mL) (K180936) | Biomerieux S.A. | 2018-07-03 |
| NeuMoDx GBS Assay (K173725) | Neumodx Molecular, Inc. | 2018-06-26 |
| VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) (K181368) | bioMerieux, Inc. | 2018-06-20 |
| ASI Evolution (K173376) | Arlington Scientific, Inc. (Asi) | 2018-06-14 |
| Aptima Combo 2 Assay (Panther System) (K180681) | Hologic, Inc. | 2018-06-13 |
| PanNAT STEC Test (K173330) | Micronics, Inc. | 2018-06-01 |
| T2Bacteria Panel (K172708) | T2biosystems, Inc. | 2018-05-24 |
| Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL (K180886) | Liofilchem s.r.l. | 2018-05-18 |
| Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K180264) | Gold Standard Diagnostics | 2018-05-02 |
| Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (K173653) | Alere Scarborough, Inc. | 2018-05-02 |
| BacterioScan 216Dx System (K172412) | Bacterioscan, Inc. | 2018-05-01 |
| Xpert Xpress Strep A (K173398) | Cepheid | 2018-04-26 |
| MALDI Biotyper CA System (DEN170081) | Bruker Daltonik GmbH | 2018-04-20 |
| Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL (K180339) | Liofilchem s.r.l. | 2018-04-04 |
| Curetis Unyvero LRT Application (DEN170047) | Curetis GmbH | 2018-04-03 |
| UriSwab-Urine Collection, Transport and Preservation System (K180052) | Copan Italia Spa | 2018-03-23 |
| Granada Medium (K173903) | Hardy Diagnostics | 2018-03-22 |
| cobas CT/NG for use on cobas 6800/8800 systems (K173887) | Roche Molecular Systems, Inc. | 2018-03-21 |
| BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438) | Bd | 2018-03-20 |
| PrimeStore MTM (DEN170029) | Longhorn Vaccines and Diagnostics, LLC | 2018-03-19 |
| Xpert CT/NG (K173840) | Cepheid | 2018-03-16 |
| BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial (K173873) | Becton, Dickinson and Company | 2018-03-16 |
| Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL (K180330) | Liofilchem s.r.l. | 2018-03-15 |
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K173798) | Diasorin Molecular, LLC | 2018-03-14 |
| BreathID Hp System (K173772) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| BreathID Hp Lab System (K173777) | Exalenz Bioscience , Ltd. | 2018-03-08 |
| Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (K173691) | Quidel Corporation | 2018-02-28 |
| Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL (K173817) | Liofilchem s.r.l. | 2018-02-28 |
| LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers (K173683) | DiaSorin, Inc. | 2018-02-27 |
| QuickVue Influenza A+B (K180288) | Quidel Corporation | 2018-02-13 |
| BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) (K173523) | Becton, Dickinson and Company | 2018-02-09 |
| Accula Flu A/Flu B Test (K171641) | Mesa Biotech, Inc. | 2018-02-06 |
| Sentosa SA201 HSV 1/2 Qualitative PCR Test (K172509) | Vela Diagnostics USA, Inc. | 2018-02-01 |
| Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (K173932) | Alere Scarborough, Inc. | 2018-01-26 |
| CAMPYLOBACTER CHEK (K173219) | Techlab, Inc. | 2018-01-22 |
| CAMPYLOBACTER QUIK CHEK (K173217) | Techlab, Inc. | 2018-01-22 |
| Xpert Carba-R (K173263) | Cepheid | 2018-01-09 |
| BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) (K173252) | Becton, Dickinson and Company | 2018-01-05 |
| MRSASelect II (K171061) | Bio-Rad | 2017-12-28 |
| Solana GBS Assay (K173250) | Quidel Corporation | 2017-12-21 |
| Sofia Strep A+ FIA, Sofia 2 Analyzer (K171976) | Quidel Corporation | 2017-12-21 |
| Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K171552) | Cepheid | 2017-12-19 |