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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For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
KAMIYA BIOMEDICAL COMPANY, LLC
K204C-10M
In Commercial Distribution

  • 00816426021013 ()
K204C-10M

  • Multiple coagulation factor IVD, control
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
KAMIYA BIOMEDICAL COMPANY, LLC
K104C-10M
Not in Commercial Distribution

  • 00816426020924 ()
K104C-10M

  • Multiple coagulation factor IVD, control
For the calibration of the K-ASSAY® Factor XIII assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-206C
In Commercial Distribution

  • 00816426020764 ()
KAI-206C

  • Coagulation factor XIII IVD, calibrator
For the calibration of the K-ASSAY® Factor XIII assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-106C
In Commercial Distribution

  • 00816426020719 ()
KAI-106C

  • Coagulation factor XIII IVD, calibrator
For the quantitative determination of human coagulation factor XIII in plasma.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-205
In Commercial Distribution

  • 00816426020535 ()
KAI-205

  • Coagulation factor XIII IVD, reagent
For the quantitative determination of human coagulation factor XIII in plasma by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-105
In Commercial Distribution

  • 00816426020467 ()
KAI-105

  • Coagulation factor XIII IVD, reagent
SEEKER™ GLA Reagent (alpha-D-galactosidase)
BAEBIES, INC.
1202
In Commercial Distribution

  • 00819704020111 ()
1202

  • Newborn metabolic screen/congenital disorder IVD, reagent
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
In Commercial Distribution

  • 04048474037968 ()
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
In Commercial Distribution

  • 04048474037937 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601-1 M
Not in Commercial Distribution

  • 04049016096764 ()


  • Influenza A/B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2010-2 G
In Commercial Distribution

  • 04049016080787 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1010-4 G
In Commercial Distribution

  • 04049016061489 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-4 G
In Commercial Distribution

  • 04049016061472 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-3 G
In Commercial Distribution

  • 04049016061335 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-1005-3 G
In Commercial Distribution

  • 04049016061311 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2730-2005-2 G
In Commercial Distribution

  • 04049016061175 ()


  • Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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 2692-9601 M
Not in Commercial Distribution

  • 04049016028352 ()


  • Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 G
In Commercial Distribution

  • 04049016028345 ()


  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2692-9601 A
Not in Commercial Distribution

  • 04049016028338 ()


  • Influenza B virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
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)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 M
Not in Commercial Distribution

  • 04049016028307 ()


  • Influenza A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 G
In Commercial Distribution

  • 04049016028291 ()


  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
NK623.OPT.A
In Commercial Distribution

  • 05051700018487 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
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
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 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 (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 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 - 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
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)
Coxsackievirus B3 Monoclonal Antibody
EMD Millipore Corporation
3306
Not in Commercial Distribution

  • 04053252404719 ()
3306

  • Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus A Control Slides
EMD Millipore Corporation
5076
Not in Commercial Distribution

  • 04053252404290 ()
5076

  • Coxsackie A/B virus antigen IVD, reagent
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
Coxsackievirus A24 Monoclonal Antibody
EMD Millipore Corporation
3302
Not in Commercial Distribution

  • 04053252326011 ()
3302

  • Coxsackie A/B virus antigen IVD, reagent
Influenza A FITC-Labeled Monoclonal Antibody
EMD Millipore Corporation
5017
Not in Commercial Distribution

  • 04053252320439 ()
5017

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