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Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

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Name
Company Name
Description
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
BD MAX™ Enteric Parasite Control Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
Cepheid Xpert® C. difficile/Epi Control Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
Assayed Respiratory Control Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
Assayed SA Nasal Complete Control Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
Assayed MRSA NxG Control Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
Assayed GBS LB Control Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
Assayed CT/NG Control Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
BD MAX™ Enteric Parasite 20-Day QC Panel
0
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QC Sets and Panels: Helix Elite™
MICROBIOLOGICS INC.
BD MAX™ CT/GC/TV 20-Day QC Panel
0
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APTIMA
Hologic, Inc.
0
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APTIMA
Hologic, Inc.
0
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APTIMA
Hologic, Inc.
0
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APTIMA
Hologic, Inc.
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek I MiniPak (An assayed nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek I Level 3 (An assayed nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek I Level 2 (An assayed nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek I Level 1 (An assayed nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek I Negative (An assayed nucleic acid control.)
0
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NATtrol™
ZEPTOMETRIX CORPORATION
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.
0
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NATtrol™
ZEPTOMETRIX CORPORATION
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.
0
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NATtrol™
ZEPTOMETRIX CORPORATION
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.
0
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BioFire JI Control Panel M420
Mmqci
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.
0
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BioFire RP2.1/RP2.1plus Control Panel M441
Mmqci
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.
0
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FilmArray BCID2 Control Panel M416
Mmqci
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.
0
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FilmArray Warrior Control Panel M290
Mmqci
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.
0
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FilmArray RP EZ Control Panel M265
Mmqci
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.
0
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FilmArray RP2/RP2plus Control Panel
Mmqci
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.
0
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FilmArray Pneumonia/Pneumoniaplus Control
Mmqci
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.
0
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BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel
BIOFIRE DEFENSE, LLC
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Level 3 MiniPak (A nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Level 2 MiniPak (A nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Level 1 MiniPak (A nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Negative MiniPak (A nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Level 3 (A nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Level 2 (A nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Level 1 (A nucleic acid control.)
0
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Amplichek
BIO-RAD LABORATORIES, INC.
Amplichek II Negative (A nucleic acid control.)
0
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MDx-Chex for BCID2
STRECK, INC.
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.