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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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EBV IgG Control Lot Data
BIO-RAD LABORATORIES, INC.
6631240
In Commercial Distribution

  • 00847865000154 ()

  • 1 Each
6631240

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
EBV IgG Control Set
BIO-RAD LABORATORIES, INC.
6631230
In Commercial Distribution

  • 00847865000147 ()

  • 4 Vials
  • Total Volume: 1.5 Milliliter
6631230

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
EBV IgG Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6631220
In Commercial Distribution

  • 00847865000130 ()

  • 1 Each
6631220

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, calibrator
EBV IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6631200
In Commercial Distribution

  • 00847865000123 ()

  • 7 Vials
  • Total Volume: 0.5 Milliliter
6631200

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, calibrator
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, calibrator
90 Test Kit SARS-CoV-2 IgG Immunoassay
QUALIGEN INC.
SARS-CoV-2 IgG Immunoassay
In Commercial Distribution

  • 00816467020389 ()
  • 10816467020386 ()
25000085

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
720-130 H.pylori IgG Test Kit
DIAMEDIX CORPORATION
720-130
In Commercial Distribution

  • 00817273020051 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Polyclonal Rabbit Anti-Human IgG/FITC Rabbit F(ab')2
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0185
In Commercial Distribution

  • 05700572031925 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, antibody
FLEX Polyclonal Rabbit Anti-Human IgG Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IS512
In Commercial Distribution

  • 05700572029687 ()

  • 20-30 Tests


  • Total immunoglobulin G (IgG total) IVD, antibody
FLEX Polyclonal Rabbit Anti-Human IgG Ready-to-Use (Link)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IR512
In Commercial Distribution

  • 05700572029380 ()

  • 40-60 Tests


  • Total immunoglobulin G (IgG total) IVD, antibody
Negative Control Mouse IgG1/RPE-Cy5, Clone DAK GO-1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0955
In Commercial Distribution

  • 05700572028499 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, control
Negative Control Mouse IgG1/RPE, Clone DAK-GO1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0928
In Commercial Distribution

  • 05700572028482 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, control
Negative Control Mouse IgG1/FITC, Clone DAK-GO1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0927
In Commercial Distribution

  • 05700572028475 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, control
Negative Control Mouse IgG2b
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0944
In Commercial Distribution

  • 05700572009641 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, control
Negative Control Mouse IgG2a
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0943
In Commercial Distribution

  • 05700572009634 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, control
Negative Control Mouse IgG1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0931
In Commercial Distribution

  • 05700572009498 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, control
Polyclonal Rabbit Anti-Human IgG/HRP
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
P0214
In Commercial Distribution

  • 05700572007340 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin G (IgG total) IVD, antibody
Polyclonal Rabbit Anti-Human IgG/FITC Rabbit F(ab')2
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0315
In Commercial Distribution

  • 05700572002697 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, antibody
Polyclonal Rabbit Anti-Human IgG/FITC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0202
In Commercial Distribution

  • 05700572002505 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin G (IgG total) IVD, antibody
Polyclonal Rabbit Anti-Human IgG
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0424
In Commercial Distribution

  • 05700572001386 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin G (IgG total) IVD, antibody
Polyclonal Rabbit Anti-Human IgG
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0423
In Commercial Distribution

  • 05700572001379 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, antibody
No Description
THE BINDING SITE GROUP LIMITED
NQ004.OPT
In Commercial Distribution

  • 05051700019095 ()


  • Total immunoglobulin G (IgG total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ004.LL.OPT
In Commercial Distribution

  • 05051700019033 ()


  • Total immunoglobulin G (IgG total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
NQ004.S
In Commercial Distribution

  • 05051700018906 ()


  • Total immunoglobulin G (IgG total) IVD, control
This reagent is for in vitro diagnostic use. IgG4 (HP6023) is intended to be used for the qualitative identification by light microscopy of human IgG4 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME systems. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0977-U
In Commercial Distribution

  • 05055331336804 ()
PA0977-U

  • Total immunoglobulin G (IgG total) IVD, antibody
Immunoglobulin G (RWP49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human immunoglobulin G (IgG) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0905-U
In Commercial Distribution

  • 05055331335494 ()
PA0905-U

  • Total immunoglobulin G (IgG total) IVD, antibody
NCL-L-IgG-U is intended for the qualitative identification by light microscopy of human immunoglobulin G (IgG) molecules in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
IGG-L-U
In Commercial Distribution

  • 05055331333865 ()
NCL-L-IGG-U

  • Total immunoglobulin G (IgG total) IVD, antibody
Immunoglobulin G (RWP49) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of immunoglobulin G in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0905
In Commercial Distribution

  • 05055331326836 ()
PA0905

  • Total immunoglobulin G (IgG total) IVD, antibody
The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma
RANDOX LABORATORIES LIMITED
IG7158
In Commercial Distribution

  • 05055273203974 ()
IG7158

  • Total immunoglobulin G (IgG total) IVD, antibody
The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma
RANDOX LABORATORIES LIMITED
IG3833
In Commercial Distribution

  • 05055273203950 ()
IG3833

  • Total immunoglobulin G (IgG total) IVD, antibody
The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma
RANDOX LABORATORIES LIMITED
IG2448
In Commercial Distribution

  • 05055273203936 ()
IG2448

  • Total immunoglobulin G (IgG total) IVD, antibody
NCL-L-IgG is intended for the qualitative identification by light microscopy of human immunoglobulin G (IgG) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
IGG-L-CE
In Commercial Distribution

  • 05055331317711 ()
NCL-L-IgG

  • Total immunoglobulin G (IgG total) IVD, antibody
Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative.
IMMUCOR, INC.
0066902
In Commercial Distribution

  • 10888234001546 ()
0066902

  • Total immunoglobulin G (IgG total) IVD, control
Fluorescein conjugated polyclonal goat antiserum to Human IgG,IgA, and IgM (polyvalent)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761162 ()
116202

  • Total immunoglobulin G (IgG total) IVD, control
No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761160 ()
116002

  • Total immunoglobulin G (IgG total) IVD, control
No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761018 ()
101872

  • Total immunoglobulin G (IgG total) IVD, control
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
Fluorescein Conjugated Antiserum to Human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761012 ()
101202

  • Total immunoglobulin G (IgG total) IVD, control
No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761011 ()
101102

  • Total immunoglobulin G (IgG total) IVD, control
Goat antiserum to Human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761010 ()
101002

  • Total immunoglobulin G (IgG total) IVD, control
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