Amplichek II Negative (A nucleic acid control.)

Amplichek II Level 1 (A nucleic acid control.)

Amplichek II Level 2 (A nucleic acid control.)

Amplichek II Level 3 (A nucleic acid control.)

Amplichek I Negative (An assayed nucleic acid control.)

Amplichek I Level 1 (An assayed nucleic acid control.)

Amplichek I Level 2 (An assayed nucleic acid control.)

Amplichek I Level 3 (An assayed nucleic acid control.)

Amplichek I MiniPak (An assayed nucleic acid control.)

Amplichek II Negative MiniPak (A nucleic acid control.)

Amplichek II Level 1 MiniPak (A nucleic acid control.)

Amplichek II Level 2 MiniPak (A nucleic acid control.)

Amplichek II Level 3 MiniPak (A nucleic acid control.)

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit

BioFire® Global Fever Special Pathogens Panel - IVD reagent kit containing 6 tests

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit

Savanna HSV 1+2/VZV Control Set

Savanna HSV 1+2/VZV Control Set

Aptima® BV assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.

Aptima® BV assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.

Aptima® BV Assay Controls Kit.

Aptima® BV Assay Calibrator.

Assayed CT/NG Control Panel

BD MAX™ CT/GC/TV 20-Day QC Panel

Assayed GBS LB Control Panel

Assayed MRSA NxG Control Panel

Assayed SA Nasal Complete Control Panel

Assayed Respiratory Control Panel

Cepheid Xpert® C. difficile/Epi Control Panel

BD MAX™ Enteric Parasite 20-Day QC Panel

BD MAX™ Enteric Parasite Control Panel

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP EZ assay on the FilmArray systems.

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray® NGDS Warrior Panel performed on FilmArray systems.

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2 and RP2plus assay on the FilmArray 2.0/Torch systems.

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems.

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Blood Culture Identification 2 (BCID2) Panel on the FilmArray systems.

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.

POS external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel and SPOTFIRE R Panel Mini

NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in the BIOFIRE SPOTFIRE R Panel and SPOTFIRE R Panel Mini

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2.1/ RP2.1plus assay on the FilmArray 2.0/Torch systems.

MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel on FilmArray® systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenza, Neisseria meningitides, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-48-like, VIM, mcr-1. Control 2 - GPY: Gram positive bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunesis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatti; antimicrobial resistance genes: mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device.

MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor theperformance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistancegenes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on LuminexVERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a bufferedsolution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components.Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcuslugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis,Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.;antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This productis not intended to replace manufacturer controls provided with the device.

MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitorthe performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobialresistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) onLuminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composedof a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture mediacomponents. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiellaoxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteusspp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: bufferedsolution only. This product is not intended to replace manufacturer controls provided with the device.

NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.