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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Radial immunodiffusion plate package for human human IgG with three standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761015 ()
101511

  • Total immunoglobulin G (IgG total) IVD, control
Radial immunodiffusion plate package for human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761014 ()
101411

  • Total immunoglobulin G (IgG total) IVD, control
IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
Beckman Coulter, Inc.
446460
In Commercial Distribution

  • 15099590230470 ()
446460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
Beckman Coulter, Inc.
447020
In Commercial Distribution

  • 15099590226985 ()
447020

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
Beckman Coulter, Inc.
446400
In Commercial Distribution

  • 15099590223885 ()
446400

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
Beckman Coulter, Inc.
447460
In Commercial Distribution

  • 15099590221225 ()
447460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
Beckman Coulter, Inc.
447470
In Commercial Distribution

  • 15099590221218 ()
447470

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
447610
In Commercial Distribution

  • 15099590221195 ()
447610

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgM
Beckman Coulter, Inc.
OSR61173
In Commercial Distribution

  • 15099590011598 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgG
Beckman Coulter, Inc.
OSR61172
In Commercial Distribution

  • 15099590011581 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IgA
Beckman Coulter, Inc.
OSR61171
In Commercial Distribution

  • 15099590011574 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
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)
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots. Note: Kit contains multiple packages.
Wallac Oy
3093-001U
In Commercial Distribution

  • 06438147356218 ()
3093-001U

  • Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry
Alinity i HAVAb IgM Reagent Kit 1000 Tests
Abbott GmbH
08P2831
In Commercial Distribution

  • 00380740136628 ()
08P2831

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alinity i HAVAb IgM Reagent Kit 200 Tests
Abbott GmbH
08P2821
In Commercial Distribution

  • 00380740136611 ()
08P2821

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Alinity i HAVAb IgM Controls
Abbott GmbH
08P2810
In Commercial Distribution

  • 00380740131579 ()
08P2810

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
Alinity i HAVAb IgM Calibrator
Abbott GmbH
08P2801
In Commercial Distribution

  • 00380740131562 ()
08P2801

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
Alinity i HAVAb IgG Reagent Kit 200 Tests
Abbott GmbH
08P2721
In Commercial Distribution

  • 00380740131371 ()
08P2721

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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 HAVAB-M Controls
Abbott GmbH
6L21-10
In Commercial Distribution

  • 00380740011086 ()
06L2110

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
ARCHITECT HAVAB-M Calibrator
Abbott GmbH
6L21-01
In Commercial Distribution

  • 00380740011079 ()
06L2101

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
HAVAb IgG II Reagent Kit 200 test
Abbott GmbH
06S9321
In Commercial Distribution

  • 00380740197650 ()
06S9321

  • Hepatitis A virus immunoglobulin G (IgG) 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 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)
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)
MONOLISA Anti-HAV IgM EIA
BIO-RAD
72495
In Commercial Distribution

  • 00847865012379 ()
72495

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
MONOLISA Anti-HAV EIA
BIO-RAD
72496
In Commercial Distribution

  • 00847865012362 ()
72496

  • Hepatitis A virus total antibody IVD, kit, enzyme immunoassay (EIA)
No Description
OXOID LIMITED
K612011-2
In Commercial Distribution

  • 05032384503841 ()


  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
No Description
OXOID LIMITED
S612130-2
In Commercial Distribution

  • 05032384503070 ()


  • Multiple-genus respiratory virus antigen IVD, control
HAV total QC kit - CENTAUR - CTL - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309005
In Commercial Distribution

  • 00630414509259 ()
1313752

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207271
In Commercial Distribution

  • 00630414301297 ()
11207271

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11207243
In Commercial Distribution

  • 00630414301259 ()
11207243

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV Total (HAVT) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995447
In Commercial Distribution

  • 00630414597775 ()
10995447

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995596
In Commercial Distribution

  • 00630414597768 ()
10995596

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) QC Kit Atellica IM - CLT 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10995445
In Commercial Distribution

  • 00630414597744 ()
10995445

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995444
In Commercial Distribution

  • 00630414597737 ()
10995444

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309522
In Commercial Distribution

  • 00630414498461 ()
7720961

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV Total - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10322682
In Commercial Distribution

  • 00630414481883 ()
5500077

  • Hepatitis A virus total antibody IVD, control
HAV Total Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10322676
In Commercial Distribution

  • 00630414481876 ()
5498862

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
HAV IgM - CENTAUR - CONS - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309084
In Commercial Distribution

  • 00630414480008 ()
5004800

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
HAV IgM Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309083
In Commercial Distribution

  • 00630414479996 ()
5004126

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
THE BINDING SITE GROUP LIMITED
NK623.S.A
In Commercial Distribution

  • 05051700017985 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK623.OPT.A
In Commercial Distribution

  • 05051700018487 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Influenza A & B Control Slides
EMD Millipore Corporation
5010-5
Not in Commercial Distribution

  • 04053252373435 ()
5010-5

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
SimulFluor® Flu A/Flu B Reagent
EMD Millipore Corporation
5250
Not in Commercial Distribution

  • 04053252368165 ()
5250

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)
SimulFluor® Flu A/Flu B Immunofluorescence Assay
EMD Millipore Corporation
3121
Not in Commercial Distribution

  • 04053252367588 ()
3121

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)
Coxsackievirus B5 Monoclonal Antibody
EMD Millipore Corporation
3308
Not in Commercial Distribution

  • 04053252332371 ()
3308

  • Coxsackie A/B virus antigen IVD, reagent
Influenza B Monoclonal Antibody
EMD Millipore Corporation
5002
Not in Commercial Distribution

  • 04053252330094 ()
5002

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Coxsackievirus B1 Monoclonal Antibody
EMD Millipore Corporation
3304
Not in Commercial Distribution

  • 04053252326264 ()
3304

  • Coxsackie A/B virus antigen IVD, reagent
SimulFluor® Flu A / Flu B Reagent
EMD Millipore Corporation
5250-5ML
Not in Commercial Distribution

  • 04053252270239 ()
5250-5ML

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)
Influenza A & B Control Slide
EMD Millipore Corporation
5010
Not in Commercial Distribution

  • 04053252789229 ()
5010

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
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