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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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Rabbit Monoclonal Anti-Human Serum Amyloid A Antibody, EP335 - 00810113068190

Rabbit Monoclonal Anti-Human Serum Amyloid A (335), 1 mL concentrated
Epitomics Inc.
AC-0311
In Commercial Distribution

  • 00810113068190 ()

  • Total Volume: 1 Milliliter


  • Serum amyloid A IVD, reagent

NA - 04260498580002

No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling

Anti-Influenza A Virus ELISA (IgA) - 04049016028284

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 A
Not in Commercial Distribution

  • 04049016028284 ()


  • Influenza A virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

ARCHITECT - 00380740011093

ARCHITECT HAVAB-M Reagent Kit
Abbott GmbH
6L21-25
In Commercial Distribution

  • 00380740011093 ()
06L2125

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740011086

ARCHITECT HAVAB-M Controls
Abbott GmbH
6L21-10
In Commercial Distribution

  • 00380740011086 ()
06L2110

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

ARCHITECT - 00380740011079

ARCHITECT HAVAB-M Calibrator
Abbott GmbH
6L21-01
In Commercial Distribution

  • 00380740011079 ()
06L2101

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator

Influenza Virus B IgG ELISA - 00404847437966

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 Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
Not in Commercial Distribution

  • 00404847437966 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza Virus A IgG ELISA - 00404847437935

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 Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
Not in Commercial Distribution

  • 00404847437935 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Light Diagnostics ™ Coxsackie A9/A24 Control Slide - 04061841171737

Coxsackie A9/A24 Control Slide
EMD Millipore Corporation
50209
Not in Commercial Distribution

  • 04061841171737 ()
50209

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackie B Control Slide - 04061841171218

Coxsackie B Control Slide
EMD Millipore Corporation
50208
Not in Commercial Distribution

  • 04061841171218 ()
50208

  • Coxsackie A/B virus antigen IVD, reagent
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