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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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Capture-R Ready Indicator Red Cells - 10888234000594

This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration.
IMMUCOR, INC.
0006427
In Commercial Distribution

  • 10888234000594 ()
0006427

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

ORTHO - 10758750003594

ANTI-IGG GRN 1X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716760
In Commercial Distribution

  • 10758750003594 ()
716760

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

ORTHO - 10758750003587

ANTI-IGG GRN 100X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716700
In Commercial Distribution

  • 10758750003587 ()
716700

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

ORTHO - 10758750003556

ANTI-IGG 1X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716360
In Commercial Distribution

  • 10758750003556 ()
716360

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

ORTHO - 10758750003549

ANTI-IGG 100X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716300
In Commercial Distribution

  • 10758750003549 ()
716300

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

MTS - 10758750005994

MTS Anti-IgG Card
MICRO TYPING SYSTEMS, INC
MTS084024
In Commercial Distribution

  • 10758750005994 ()
MTS084024

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

Anti-Human Globulin Anti-IgG - Clear - 23661562105490

Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.
DIAGAST
210549
In Commercial Distribution

  • 23661562105490 ()
  • 13661562105493 ()
210549

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

Anti-Human Globulin Anti-IgG - Green - 23661562105476

Anti-Human Globulin Anti-IgG (Murine Monoclonal) (18833+18896) is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.
DIAGAST
210547
In Commercial Distribution

  • 23661562105476 ()
  • 13661562105479 ()
210547

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

BioPlex 2200 - 00847865000413

ToRC IgG Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6631620
In Commercial Distribution

  • 00847865000413 ()

  • 1 Each
6631620

  • Rubella virus immunoglobulin G (IgG) antibody IVD, calibrator
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, calibrator
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator

BioPlex 2200 - 00847865000406

ToRC IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6631600
In Commercial Distribution

  • 00847865000406 ()

  • Total Volume: 0.5 Milliliter
  • 6 Vials
6631600

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, calibrator
  • Rubella virus immunoglobulin G (IgG) antibody IVD, calibrator
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, calibrator

BioPlex 2200 - 00847865000154

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

BioPlex 2200 - 00847865000147

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

BioPlex 2200 - 00847865000130

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

BioPlex 2200 - 00847865000123

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

FastPack SARS-CoV-2 IgG - 10816467020386

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

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

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 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

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

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
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