SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(6101 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
NEOCOIL, LLC
41
In Commercial Distribution

  • 00856181003411 ()


  • Headphones
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.
Mmqci
v.00
In Commercial Distribution

  • 00852720008121 ()
M420

  • Escherichia coli nucleic acid IVD, control
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.
Mmqci
v.00
In Commercial Distribution

  • 00852720008077 ()
M416

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008060 ()
C130

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
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.
Mmqci
v.00
In Commercial Distribution

  • 00852720008053 ()
M290

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
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.
Mmqci
v.00
Not in Commercial Distribution

  • 00852720008039 ()
M315

  • Multiple-genus respiratory virus nucleic acid IVD, control
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Mmqci
v.02
In Commercial Distribution

  • 00852720008015 ()
G106ac

  • Cystic fibrosis IVD, control
This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Mmqci
v.02
In Commercial Distribution

  • 00852720008008 ()
G106ac-1

  • Cystic fibrosis IVD, control
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
AKERS BIOSCIENCES, INC.
4036028
In Commercial Distribution

  • 00708872000011 ()
  • 01708872000011 ()
4036028

  • Platelet factor 4-heparin complex antibody IVD, control
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