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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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Diamedix - 00817273020051

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

IgG - 05055273203950

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

IgG - 05055273203936

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

Optilite® IgG Control Pack - 05051700019095

No Description
THE BINDING SITE GROUP LIMITED
NQ004.OPT
In Commercial Distribution

  • 05051700019095 ()


  • Total immunoglobulin G (IgG total) IVD, control

IgG - 05055273203974

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

Novocastra - 05055331317711

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

BOND™ - 05055331326836

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

BOND - 05055331336804

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

BOND - 05055331335494

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

Novocastra - 05055331333865

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

Poly Rb A-Hu IgG/FITC Rb F(ab')2 - 05700572031925

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 Poly Rb A-Hu IgG RTU - 05700572029687

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 Poly Rb A-Hu IgG RTU (Link) - 05700572029380

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 Mo IgG2b - 05700572009641

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 Mo IgG2a - 05700572009634

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 Mo IgG1 - 05700572009498

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

Poly Rb A-Hu IgG/HRP - 05700572007340

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

Poly Rb A-Hu IgG/FITC Rb F(ab')2 - 05700572002697

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

Poly Rb A-Hu IgG/FITC - 05700572002505

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

Poly Rb A-Hu IgG - 05700572001386

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

Poly Rb A-Hu IgG - 05700572001379

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

Negative Control Mo IgG1/RPE-Cy5, Cl DAK-GO1 - 05700572028499

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 Mo IgG1/RPE, Cl DAK-GO1 - 05700572028482

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 Mo IgG1/FITC, Cl DAK-GO1 - 05700572028475

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

IgG control slides - B502BSB36860

IgG Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36860 ()
BSB 3686

  • Total immunoglobulin G (IgG total) IVD, control

IgG control slides - B502BSB56790

IgG, control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56790 ()
BSB 5679

  • Total immunoglobulin G (IgG total) IVD, control

IgG MMab - B502BSB56780

IgG is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB56780 ()
BSB 5678

  • Total immunoglobulin G (IgG total) IVD, antibody

IgG MMab - B502BSB56770

IgG is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB56770 ()
BSB 5677

  • Total immunoglobulin G (IgG total) IVD, antibody

IgG MMab - B502BSB56760

IgG is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56760 ()
BSB 5676

  • Total immunoglobulin G (IgG total) IVD, antibody

Tinto IgG MMab - B502BSB56750

IgG is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56750 ()
BSB 5675

  • Total immunoglobulin G (IgG total) IVD, antibody

Tinto IgG MMab - B502BSB56740

IgG antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in Phosphate Buffered Saline, pH 7.6, with protein base, and preserved with Sodium Azide preservative.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56740 ()
BSB 5674

  • Total immunoglobulin G (IgG total) IVD, antibody

Tinto IgG - B502BSB56730

IgG antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in Phosphate Buffered Saline, pH 7.6
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56730 ()
BSB 5673

  • Total immunoglobulin G (IgG total) IVD, antibody

IHC - 00810170553462

No Description
Slmp, LLC
(BTO) Sample IgG Antibody (2ml)
In Commercial Distribution

  • 00810170553462 ()
SAM-RP08-2

  • Total immunoglobulin G (IgG total) IVD, antibody

IHC - 00810170552090

IgG Antibody, 10ml
Slmp, LLC
(BTO) RTU IgG Antibody (10ml)
In Commercial Distribution

  • 00810170552090 ()
RP08-10

  • Total immunoglobulin G (IgG total) IVD, antibody

IHC - 00810170550126

IgG Antibody with FITC tag 1ml
Slmp, LLC
IgG Antibody with FITC tag 1ml
In Commercial Distribution

  • 00810170550126 ()
FITC-008-01

  • Total immunoglobulin G (IgG total) IVD, antibody

Anti Human Immunoglobulins IgG, IgA, and IgM FITC - B1761162

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

Antiserum to Human IgG, IgA and IgM - B1761160

No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761160 ()
116002

  • Total immunoglobulin G (IgG total) IVD, control

Peroxidase conjugated Antiserum to Human IgG - B1761018

No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761018 ()
101872

  • Total immunoglobulin G (IgG total) IVD, control

IgG RID Plate Kit - B1761015

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

IgG RID Plate Package - B1761014

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

  • B1761014 ()
101411

  • Total immunoglobulin G (IgG total) IVD, control

Anti Human IgG FITC - B1761012

Fluorescein Conjugated Antiserum to Human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761012 ()
101202

  • Total immunoglobulin G (IgG total) IVD, control

Rhodamine conjugated antiserum to Human IgG - B1761011

No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761011 ()
101102

  • Total immunoglobulin G (IgG total) IVD, control

Antiserum to Human IgG (gamma chain specific) - B1761010

Goat antiserum to Human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761010 ()
101002

  • Total immunoglobulin G (IgG total) IVD, control

Optilite® Low Level IgG Control Pack - 05051700019033

No Description
THE BINDING SITE GROUP LIMITED
NQ004.LL.OPT
In Commercial Distribution

  • 05051700019033 ()


  • Total immunoglobulin G (IgG total) IVD, control

Human IgG Control Pack for use on the SPAPLUS® - 05051700018906

No Description
THE BINDING SITE GROUP LIMITED
NQ004.S
In Commercial Distribution

  • 05051700018906 ()


  • Total immunoglobulin G (IgG total) IVD, control

Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum - 10888234001546

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

IgG RMab - B502BSB30790

IgG is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB30790 ()
BSB 3079

  • Total immunoglobulin G (IgG total) IVD, antibody

IgG, RPab - B502BSB30780

IgG is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB30780 ()
BSB 3078

  • Total immunoglobulin G (IgG total) IVD, antibody

IgG, RPab - B502BSB30770

IgG is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB30770 ()
BSB 3077

  • Total immunoglobulin G (IgG total) IVD, antibody

Tinto IgG, RPab - B502BSB30760

IgG is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB30760 ()
BSB 3076

  • Total immunoglobulin G (IgG total) IVD, antibody
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