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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
Roche Diagnostics GmbH
08086630190
In Commercial Distribution

  • 07613336129722 ()
08086630190

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08086664190
In Commercial Distribution

  • 07613336129715 ()
08086664190

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3796
In Commercial Distribution

  • 00840239037961 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3793
In Commercial Distribution

  • 00840239037930 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilization cycle of a V-PRO Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology.
ALBERT BROWNE LIMITED
PCC079
In Commercial Distribution

  • 50724995218589 ()
  • 10724995218581 ()
  • 00724995218584 ()
PCC079

  • Chemical/physical sterilization process indicator
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution

  • ENTIINFG03000 ()
INFG0300

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Acute Hemodialysis Accessory Tray
ARGON MEDICAL DEVICES, INC.
500331A
Not in Commercial Distribution

  • 20886333215861 ()
  • 00886333215867 ()
500331A

  • General surgical procedure kit, medicated
Hemodialysis Pack
ARGON MEDICAL DEVICES, INC.
500326D
Not in Commercial Distribution

  • 20886333215847 ()
  • 00886333215843 ()
500326D

  • General surgical procedure kit, medicated
Acute Hemodialysis Tray
ARGON MEDICAL DEVICES, INC.
500320F
Not in Commercial Distribution

  • 20886333215830 ()
  • 00886333215836 ()
500320F

  • General surgical procedure kit, medicated
D3 Duet DFA Influenza A/Respiratory Virus Screening kit
DIAGNOSTIC HYBRIDS, INC.
01-200000
In Commercial Distribution

  • 30014613330882 ()
01-200000

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
FASTPOINT FLUA/B KIT BX 2
DIAGNOSTIC HYBRIDS, INC.
01-120001.B2
In Commercial Distribution

  • 30014613330806 ()
01-120001.B2

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
FASTPOINT FLUA/B KIT BX 1
DIAGNOSTIC HYBRIDS, INC.
01-120001.B1
In Commercial Distribution

  • 30014613330790 ()
01-120001.B1

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
FASTPOINT FLUA/B KIT
DIAGNOSTIC HYBRIDS, INC.
01-120001
In Commercial Distribution

  • 30014613330783 ()
01-120001

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Parainfluenza 3 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013702.V2
In Commercial Distribution

  • 30014613330479 ()
01-013702.V2

  • Human parainfluenza virus 3 antigen IVD, kit, fluorescent immunoassay
Parainfluenza 2 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013602.V2
In Commercial Distribution

  • 30014613330462 ()
01-013602.V2

  • Human parainfluenza virus 2 antigen IVD, kit, fluorescent immunoassay
Parainfluenza 1 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013502.V2
In Commercial Distribution

  • 30014613330455 ()
01-013502.V2

  • Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay
D3 DFA 500 ML SCR REAGENT
DIAGNOSTIC HYBRIDS, INC.
01-013500.V2-BULK
In Commercial Distribution

  • 30014613330448 ()
01-013500.V2-BULK

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Adeno DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013402.V2
In Commercial Distribution

  • 30014613330431 ()
01-013402.V2

  • Adenovirus antigen IVD, kit, fluorescent immunoassay
RSV DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013302.V2
In Commercial Distribution

  • 30014613330424 ()
01-013302.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
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