| Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL (K173307) | Liofilchem s.r.l. | 2017-12-19 |
| VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL (K172944) | bioMerieux, Inc. | 2017-12-19 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) (K172337) | Beckman Coulter, Inc. | 2017-12-15 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K173502) | Alere Scarborough, Inc. | 2017-12-13 |
| T2Candida 1.1 Panel (K173536) | T2biosystems, Inc. | 2017-12-12 |
| Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) (K172722) | Euroimmun Us, Inc. | 2017-12-10 |
| Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set (K172713) | Fujirebio Diagnostics,Inc. | 2017-12-10 |
| VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) (K172731) | bioMerieux, Inc. | 2017-12-08 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) (K172912) | Beckman Coulter, Inc. | 2017-12-07 |
| Panther Fusion AdV/hMPV/RV Assay (K172629) | Hologic, Inc. | 2017-12-04 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL (K173209) | Thermo Fisher Scientific | 2017-12-01 |
| MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) (K172255) | Beckman Coulter, Inc. | 2017-12-01 |
| GeneSTAT.MDx Coccidioides Assay (DEN170041) | Dxna, LLC | 2017-11-29 |
| FilmArray RP2/RP2plus Control Panel (K173171) | Maine Molecular Quality Controls, Inc. | 2017-11-24 |
| GenePOC CDiff (K172569) | Genepoc, Inc. | 2017-11-22 |
| ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (K172402) | Luminex Corporation | 2017-10-30 |
| Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. (K172542) | Liofilchem s.r.l. | 2017-10-23 |
| Lyme B. burgdorferi (IgM) MarStripe Test (K172254) | Trinity Biotech | 2017-10-23 |
| Panther Fusion Paraflu Assay (K172282) | Hologic, Inc. | 2017-10-23 |
| Sofia Lyme FIA, Sofia Lyme Control Set (K163713) | Quidel Corporation | 2017-10-20 |
| Solana RSV+hMPV Assay (K171974) | Quidel Corporation | 2017-10-16 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL (K172454) | Thermo Fisher Scientific | 2017-10-13 |
| HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) (K172621) | Hardy Diagnostics | 2017-10-03 |
| Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K171792) | Alere Scarborough, Inc. | 2017-09-29 |
| Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL (K172109) | Liofilchem s.r.l. | 2017-09-27 |
| Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes (K171963) | Hologic, Inc. | 2017-09-26 |
| Xpert Xpress Strep A (K172126) | Cepheid | 2017-09-25 |
| Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) (K172150) | bioMerieux, Inc. | 2017-09-15 |
| cobas Cdiff Nucleic acid test for use on the cobas Liat System (K171770) | Roche Molecular Systems, Inc. | 2017-09-12 |
| The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL (K172274) | Thermo Fisher Scientific | 2017-08-30 |
| Idylla Respiratory (IFV-RSV) Panel (K163628) | Janssen Pharmaceutica NV | 2017-08-30 |
| Borrelia B31 ViraChip IgM Test Kit (K163695) | Viramed Biotech AG | 2017-08-22 |
| RIDA GENE Norovirus GI/GII (K171511) | R-Biopharm AG | 2017-08-21 |
| ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (DEN160025) | Id-Fish Technology, Inc. | 2017-08-18 |
| 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/H5 Subtyping Kit (K172091) | Centers for Disease Control and Prevention | 2017-08-09 |
| iC-GPC Assay TM for use on the iC-SystemTM (K163390) | Icubate, Inc. | 2017-08-08 |
| Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL (K171906) | Liofilchem s.r.l. | 2017-08-01 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL (K171870) | Thermo Fisher Scientific | 2017-08-01 |
| HardyDisk AST Delafloxacin 5 µg (DLX5) (K171975) | Hardy Diagnostics | 2017-08-01 |
| MALDI Biotyper CA (MBT-CA) System, MBT smart CA System (K163536) | Bruker Daltonik GmbH | 2017-07-26 |
| VITEK MS (K162950) | bioMerieux, Inc. | 2017-07-22 |
| ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit (K171441) | Luminex Corporation | 2017-07-21 |
| Borrelia B31 ViraChip IgG Test Kit (K163504) | Viramed Biotech AG | 2017-07-12 |
| Great Basin Stool Bacterial Pathogens Panel (K163571) | Great Basin Scientific, Inc. | 2017-07-12 |
| TRI-COMBO PARASITE SCREEN (K171078) | Techlab, Inc. | 2017-07-10 |
| Rickettsia Real-time PCR Assay (K170940) | Centers For Disease Control and Prevention (CDC) | 2017-06-29 |
| Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (K162678) | Roche Diagnostics | 2017-06-23 |
| VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) (K162737) | bioMerieux, Inc. | 2017-06-21 |
| Aptima Herpes Simplex Viruses 1 & 2 Assay (K162673) | Hologic, Inc. | 2017-06-15 |
| ePlex Respiratory Pathogen Panel (K163636) | Genmark Diagnostics, Incorporated | 2017-06-09 |
| Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL (K170772) | Liofilchem s.r.l. | 2017-06-07 |
| E. HISTOLYTICA QUIK CHEK (K170728) | Techlab, Inc. | 2017-06-07 |
| ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls (K170652) | Fisher Diagnostics | 2017-06-01 |
| B R A H M S PCT sensitive KRYPTOR (K171338) | Brahms GmbH | 2017-05-31 |
| Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) (K170670) | bioMerieux, Inc. | 2017-05-31 |
| FilmArray Respiratory Panel 2 (RP2) (K170604) | Biofire Diagnostics, LLC | 2017-05-30 |
| Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL (K170892) | Liofilchem s.r.l. | 2017-05-25 |
| GenePOC GBS LB (K170557) | Genepoc, Inc. | 2017-05-25 |
| Strep B Carrot Broth One-Step (K170586) | Hardy Diagnostics | 2017-05-22 |
| BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (K170509) | Bio-Rad Laboratories | 2017-05-19 |
| Strep B Carrot Broth Kit (K170481) | Hardy Diagnostics | 2017-05-16 |
| BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (K170413) | Bio-Rad Laboratories | 2017-05-11 |
| Solana C. difficile Assay (K170491) | Quidel Corporation | 2017-05-11 |
| BD MAX Extended Enteric Bacterial Panel, BD MAX System (K170308) | Becton, Dickinson and Company | 2017-05-02 |
| ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (K163626) | Luminex Corporation | 2017-05-02 |
| Remel Spectra ESBL (K162620) | Remel, Inc. | 2017-05-01 |
| RAPIDEC CARBA NP (K162385) | Biomerieux S.A. | 2017-04-27 |
| Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set (K162297) | Diazyme Laboratories | 2017-04-18 |
| Sofia Influenza A+B FIA on Sofia 2 (K162438) | Quidel Corporation | 2017-04-14 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K162642) | Alere Scarborough, Inc. | 2017-04-10 |
| Great Basin Bordetella Direct Test (K170284) | Great Basin Scientific, Inc. | 2017-03-31 |
| BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816) | bioMerieux, Inc. | 2017-03-28 |
| BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) (K163637) | Becton Dickinson & Company | 2017-03-21 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) (K162740) | Beckman Coulter, Inc. | 2017-03-21 |
| Elecsys CMV IgM (K163569) | Roche Diagnostics | 2017-03-17 |
| HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 (K170127) | Hardy Diagnostics | 2017-03-14 |
| FilmArray Warrior Control Panel M290 (K163522) | Maine Molecular Quality Controls, Inc. | 2017-03-14 |
| Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL (K163517) | Liofilchem s.r.l. | 2017-03-14 |
| VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) (K163563) | bioMerieux, Inc. | 2017-03-13 |
| Greiner Vacuette Urine Count and Culture, Mannitol tube (K163436) | Greiner Bio-One Na, Inc. | 2017-03-06 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K162827) | bioMerieux, Inc. | 2017-02-23 |
| Accelerate Pheno system, Accelerate Phenotest BC Kit (DEN160032) | Accelerate Diagnotics | 2017-02-23 |
| Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL (K163298) | Liofilchem s.r.l. | 2017-02-22 |
| Sofia RSV FIA on Sofia 2 analyzer (K162911) | Quidel Corporation | 2017-02-22 |
| TRU Legionella (K163273) | Meridian Bioscience, Inc. | 2017-02-21 |
| SeptiCyte LAB (K163260) | Immunexpress, Inc. | 2017-02-17 |
| VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) (K161437) | bioMerieux, Inc. | 2017-02-16 |
| Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack (K163085) | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC | 2017-02-14 |
| VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) (K161510) | bioMerieux, Inc. | 2017-02-13 |
| Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K162456) | Cepheid | 2017-02-13 |
| Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K162331) | Cepheid | 2017-02-09 |
| cobas® CT/NG v2.0 Test (K163184) | Roche Molecular Systems, Inc. | 2017-02-09 |
| BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810) | Becton Dickinson | 2017-02-09 |
| Variola virus Real-Time PCR Assay (DEN160016) | Centers For Disease Control and Prevention (CDC) | 2017-02-06 |
| VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) (K163083) | bioMerieux, Inc. | 2017-02-01 |
| Lyme B. burgdorferi (IgG) MarStripe Test (K163095) | Trinity Biotech | 2017-02-01 |
| chromID Strepto B agar (K163042) | bioMerieux, Inc. | 2017-01-27 |
| VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) (K163006) | bioMerieux, Inc. | 2017-01-24 |
| VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) (K161217) | bioMerieux, Inc. | 2017-01-12 |
| LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (K162969) | DiaSorin, Inc. | 2017-01-06 |