SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8542 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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BioFire® Global Fever Panel - 00851458005242

BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
BIOFIRE DEFENSE, LLC
DFA2-ASY-0004
In Commercial Distribution

  • 00851458005242 ()
DFA2-ASY-0004

  • Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® NGDS Warrior Panel - 00851458005136

FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0007
In Commercial Distribution

  • 00851458005136 ()
NGDS-ASY-0007

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

PCE Pen Panel Transmitter Box - 00856181003411

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

BioFire JI Control Panel M420 - 00852720008121

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

FilmArray BCID2 Control Panel M416 - 00852720008077

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

Xpert BCR-ABL IS Panel C130 - 00852720008060

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

FilmArray Warrior Control Panel M290 - 00852720008053

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

FilmArray RP2/RP2plus Control Panel - 00852720008039

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

INTROL CF Panel I Control - 00852720008015

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

INTROL CF Panel I Control - 00852720008008

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
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