| LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set (K162961) | DiaSorin, Inc. | 2017-01-05 |
| LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (K162959) | DiaSorin, Inc. | 2017-01-04 |
| ARIES GBS Assay (K162772) | Luminex Corporation | 2016-12-23 |
| Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (K163266) | Alere Scarborough, Inc. | 2016-12-21 |
| Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml (K162854) | Liofilchem s.r.l. | 2016-12-19 |
| Chagas Detect Plus Rapid Test (K161947) | InBios International, Inc. | 2016-12-16 |
| Solana HSV 1+2/VZV Assay (K162451) | Quidel Corporation | 2016-11-28 |
| Xpert MRSA NxG (K162444) | Cepheid | 2016-11-23 |
| HardyCHROM ESBL (K160512) | Hardy Diagnostics | 2016-11-15 |
| Puritan Fecal Opti-Swab Collection and Transport System (K162284) | Puritan Medical Products, LLC | 2016-11-04 |
| BreathID Hp Lab System (K162150) | Exalenz Bioscience , Ltd. | 2016-10-31 |
| BD MAX Vaginal Panel, BD MAX Instrument (DEN160001) | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016-10-28 |
| Solana Strep Complete Assay (K162274) | Quidel Corporation | 2016-10-25 |
| chromID MRSA (K162076) | bioMerieux, Inc. | 2016-10-25 |
| ADVIA Centaur HAV IgM Assay (K161964) | Siemens Healthcare Diagnostics, Inc. | 2016-10-13 |
| APAS Compact with Urine Analysis Module (DEN150059) | Clever Culture Systems AG | 2016-10-06 |
| FilmArray Respiratory Panel EZ (RP EZ) (K152579) | Biofire Diagnostics, LLC | 2016-10-03 |
| SeraQuest Herpes Type 1 Specific IgG (K162276) | Quest International, Inc. | 2016-10-01 |
| Solana Influenza A+B Assay (K161814) | Quidel Corporation | 2016-09-27 |
| FilmArray RP EZ Control Panel M265 (K161573) | Maine Molecular Quality Controls, Inc. | 2016-09-02 |
| LIAISON HAV IgM, LIAISON Control HAV IgM (K160650) | DiaSorin, Inc. | 2016-08-25 |
| Anti-Borrelia burgdorferi US Westernblot (IgG) (K161513) | Euroimmun US | 2016-08-25 |
| Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (K161375) | Alere Scarborough, Inc. | 2016-08-18 |
| EUROIMMUN Anti-West Nile Virus ELISA (IgM) (K153308) | Euroimmun Us, Inc. | 2016-08-12 |
| EUROIMMUN Anti-West Nile Virus ELISA (IgG) (K153303) | Euroimmun Us, Inc. | 2016-08-10 |
| BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306) | Becton Dickinson | 2016-08-08 |
| ARIES® Flu A/B & RSV Assay (K161220) | Luminex Corporation | 2016-08-02 |
| Puritan Opti-Tranz Cary-Blair Collection and Transport System (K160082) | Puritan Medical Products, LLC | 2016-07-29 |
| Elecsys Syphilis (K160910) | Roche Diagnostics | 2016-07-28 |
| cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System (K153544) | Iquum, Inc. | 2016-07-25 |
| LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (K161139) | DiaSorin, Inc. | 2016-07-22 |
| VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) (K161227) | bioMerieux, Inc. | 2016-07-20 |
| Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL (K161175) | Liofilchem s.r.l. | 2016-07-12 |
| Lumipulse G TP-N Immunoreaction Cartridge Set (K153145) | Fujirebio Diagnostics,Inc. | 2016-07-05 |
| CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (K161556) | Centers For Disease Control and Prevention (CDC) | 2016-06-30 |
| Xpert Carba-R (K160901) | Cepheid | 2016-06-29 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K160911) | bioMerieux, Inc. | 2016-06-28 |
| Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml (K153569) | Liofilchem s.r.l. | 2016-06-22 |
| ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (K153730) | Abbott Laboratories | 2016-06-15 |
| Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (K160729) | Roche Diagnostics | 2016-06-13 |
| illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 (K160829) | Meridian Bioscience, Inc. | 2016-06-13 |
| SeraQuest HSV Type 2 Specific IgG (K152353) | Quest International, Inc. | 2016-05-13 |
| 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 |
| VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) (K152075) | bioMerieux, Inc. | 2016-04-15 |
| FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (K160459) | Biofire Diagnostics, LLC | 2016-04-01 |
| Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL (K153687) | Liofilchem s.r.l. | 2016-03-31 |
| 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 |
| VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) (K151923) | bioMerieux, Inc. | 2016-03-25 |
| Great Basin Staph ID/R Blood Culture Panel (K152470) | Great Basin Scientific, Inc. | 2016-03-25 |
| Great Basin Shiga Toxin Direct Test (K152955) | Great Basin Scientific, Inc. | 2016-03-22 |
| FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch (K160462) | Biofire Diagnostics, LLC | 2016-03-17 |
| FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (K160457) | Biofire Diagnostics, LLC | 2016-03-15 |
| ImmunoCard STAT! HpSA (K153661) | Meridian Bioscience, Inc. | 2016-03-14 |
| chromID MRSA (K151688) | bioMerieux, Inc. | 2016-03-11 |
| Xpert Carba-R (K152614) | Cepheid | 2016-03-07 |
| BD Veritor System for Rapid Detection of Flu A + B Labratory Kit (K160164) | Becton, Dickinson & CO | 2016-02-25 |
| BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866) | Becton, Dickinson and Company | 2016-02-25 |
| BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K160161) | Becton, Dickinson & CO | 2016-02-24 |
| B.R.A.H.M.S PCT sensitive KRYPTOR (DEN150009) | Brahms GmbH | 2016-02-20 |
| VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL (K151817) | bioMerieux, Inc. | 2016-02-18 |
| FilmArray Respiratory Panel (RP) for use with FilmArray Torch (K160068) | Biofire Diagnostics, LLC | 2016-02-08 |
| BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml (K151320) | Becton, Dickinson and Company | 2016-01-15 |
| Sofia Influenza A+B FIA (K153012) | Quidel Corporation | 2016-01-12 |
| ADVIA Centaur Toxoplasma M (Toxo M) (K142826) | Siemens Healthcare Diagnostics, Inc. | 2015-12-22 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL (K152774) | Thermo Fisher Scientific | 2015-12-21 |
| NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K152386) | Luminex Molecular Diagnostics, Inc. | 2015-12-17 |
| ProParaFlu+ Assay (K153223) | Hologic, Inc. | 2015-12-09 |
| Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (K151226) | Cepheid | 2015-12-03 |
| CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping (K153148) | Centers For Disease Control and Prevention (CDC) | 2015-12-01 |
| HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 (K152846) | Hardy Diagnostics | 2015-11-24 |
| HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 (K152838) | Hardy Diagnostics | 2015-11-24 |
| ProFlu+ Assay (K153219) | Hologic, Inc. | 2015-11-20 |
| Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K150358) | Gold Standard Diagnostics | 2015-11-12 |
| illumigene Pertussis DNA Amplification Assay (K152285) | Meridian Bioscience, Inc. | 2015-11-10 |
| BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit (K152870) | Becton, Dickinson and Co. | 2015-10-27 |
| BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit (K152874) | Becton, Dickinson and Co. | 2015-10-27 |
| illumigene Mycoplasma DNA Amplification Assay (K152800) | Meridian Bioscience, Inc. | 2015-10-23 |
| BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks (K152516) | Becton, Dickinson and Company | 2015-10-13 |
| FilmArray Meningitis/Encephalitis(ME) Panel (DEN150013) | Biofire Diagnostics, LLC | 2015-10-08 |
| Etest Ceftaroline (0.002 - 32ug/ml) (K151873) | Biomerieux S.A. | 2015-10-07 |
| ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) (K151906) | Luminex Corporation | 2015-10-06 |
| hemoFISH Masterpanel (K150031) | Miacom Diagnostics GmbH | 2015-10-01 |
| JBAIDS Influenza A & B Detection Kit (K152523) | U.S Army Medical Materiel Development Activity | 2015-10-01 |
| Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (K152408) | Focus Diagnostics, Inc. | 2015-09-21 |
| MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) (K152346) | Beckman Coulter, Inc. | 2015-09-16 |
| Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (K143653) | Nanosphere, Inc. | 2015-09-04 |
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K150962) | Focus Diagnostics | 2015-08-28 |
| Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) (K150556) | Thermo Fisher Scientific | 2015-08-28 |
| BD MAX Enteric Parasite Panel, BD MAX Instrument (K143648) | Becton, Dickinson and Company | 2015-08-25 |
| Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (K151935) | Alere San Diego, Incorporated | 2015-08-12 |
| Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K151464) | Alere Scarborough, Inc. | 2015-07-28 |
| Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) (K150236) | Thermo Fisher Scientific | 2015-07-27 |
| illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 (K151046) | Meridian Bioscience, Inc. | 2015-07-17 |
| VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (K141133) | BIOMERIEUX | 2015-07-09 |
| Theranos Herpes Simplex Virus-1 IgG Assay (K143236) | Theranos, Inc. | 2015-07-02 |
| MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (K150039) | Siemens Healthcare Diagnostics, Inc. | 2015-07-02 |
| Solana GAS Assay, Solana instrument (K150868) | Quidel Corporation | 2015-06-23 |
| BD Veritor (TM) System for the Rapid Detection of Flu A+B (K151291) | Becton, Dickinson and Company | 2015-06-10 |
| BD Veritor™ System Flu A+B Assay (K151301) | Becton, Dickinson and Company | 2015-06-08 |
| cobas HSV 1 and 2 Test (K150617) | Roche Molecular Systems, Inc. | 2015-06-01 |