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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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Gram-Negative Blood Culture (BC-GN) Utility Tray - 00840487101698

The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
LUMINEX CORPORATION
20-011-021
In Commercial Distribution

20-011-021

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

Enteric Pathogens (EP) Amplification Tray - 00840487101544

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-011-023
In Commercial Distribution

20-011-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

VITROS - 10758750034642

VITROS Immunodiagnostic Products CK-MB Calibrators
ORTHO CLINICAL DIAGNOSTICS
6199329
In Commercial Distribution

  • 10758750034642 ()
  • 20758750034649 ()
6199329

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034581

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199976
In Commercial Distribution

  • 10758750034581 ()
6199976

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034420

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

i-STAT - 00054749004973

I-STAT TBI Control L2
ABBOTT POINT OF CARE INC.
06P17-26
In Commercial Distribution

  • 00054749004973 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT - 00054749004966

I-STAT TBI Control L1
ABBOTT POINT OF CARE INC.
06P17-25
In Commercial Distribution

  • 00054749004966 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT - 00054749004959

I-STAT TBI Calibration Verification Set
ABBOTT POINT OF CARE INC.
06P17-24
In Commercial Distribution

  • 00054749004959 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT hs-TnI Control Level 3 - 00054749004942

i-STAT hs-TnI Control Level 3
Abbott Point of Care Inc.
06P17-23
In Commercial Distribution

  • 00054749004942 ()
06P17-23

  • Troponin I IVD, control

i-STAT hs-TnI Control Level 2 - 00054749004935

i-STAT hs-TnI Control Level 2
Abbott Point of Care Inc.
06P17-22
In Commercial Distribution

  • 00054749004935 ()
06P17-22

  • Troponin I IVD, control
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