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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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-2 G
In Commercial Distribution

  • 04049016061151 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-1 G
In Commercial Distribution

  • 04049016060994 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601-1 G
Not in Commercial Distribution

  • 04049016028321 ()


  • Influenza A/B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3905
Not in Commercial Distribution

  • 00840487101285 ()
3905

  • Influenza B virus nucleic acid IVD, reagent
RSV Positive Control is an external control reagent to be used with TRU RSV Test Kits as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
751110
In Commercial Distribution

  • 00840733103476 ()
751110

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control
FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
MERIDIAN BIOSCIENCE, INC.
751110
Not in Commercial Distribution

  • 00840733101977 ()
751110

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control
IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent
Beckman Coulter, Inc.
447480
In Commercial Distribution

  • 15099590233242 ()
447480

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, enzyme immunoassay (EIA)
IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent
Beckman Coulter, Inc.
447760
In Commercial Distribution

  • 15099590224073 ()
447760

  • Complement factor B IVD, reagent
Validate LP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
507ro
In Commercial Distribution

  • 00859110005869 ()

  • 2 tests
507ro

  • Apolipoprotein A-I (Apo A1) IVD, control
  • Apolipoprotein B (Apo B) IVD, control
  • Multiple lipid analyte IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0063
In Commercial Distribution

  • 00816784020932 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
  • Multiple blood-borne virus antigen/antibody IVD, control
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