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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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ACCURUN® - 00816784020413

ACCURUN 140 Rubella IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0084
In Commercial Distribution

  • 00816784020413 ()
2015-0084

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

Drew Scientific - 00817274020135

Gold Kit 80-100 Test
DREW SCIENTIFIC, INC.
014-080
In Commercial Distribution

  • 00817274020135 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, control

Mumps IgG Control - B110MUG80200

No Description
Bion Enterprises, Ltd.
MUG-8020
In Commercial Distribution

  • B110MUG80200 ()
MUG-8020

  • Mumps virus immunoglobulin G (IgG) antibody IVD, control

CMV IgG Control - B110CMG20200

No Description
Bion Enterprises, Ltd.
CMG-2020
In Commercial Distribution

  • B110CMG20200 ()
CMG-2020

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Measles IgG Control - B110MEG60200

No Description
Bion Enterprises, Ltd.
MEG-6020
In Commercial Distribution

  • B110MEG60200 ()
MEG-6020

  • Measles virus immunoglobulin G (IgG) antibody IVD, control

PreciControl Anti-CMV - 07613336183151

No Description
Roche Diagnostics GmbH
04784600162
In Commercial Distribution

  • 07613336183151 ()
04784600162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

PreciControl Release Anti-CMV - 07613336182987

No Description
Roche Diagnostics GmbH
09366679190
In Commercial Distribution

  • 07613336182987 ()
09366679190

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, control

Anti-Adenovirus IFA (IgG) - 04049016059417

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-2005 G
Not in Commercial Distribution

  • 04049016059417 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Adenovirus IFA (IgG) - 04049016059400

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-1010 G
Not in Commercial Distribution

  • 04049016059400 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Adenovirus IFA (IgG) - 04049016059394

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-1005 G
Not in Commercial Distribution

  • 04049016059394 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Adenovirus IFA (IgG) - 04049016059387

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2680-1003 G
Not in Commercial Distribution

  • 04049016059387 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ADVIA Centaur CMV IgG QC - 00630414587448

CMV IgG ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10630613
In Commercial Distribution

  • 00630414587448 ()
  • 00630414224138 ()
10630613

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Atellica™ IM HBeAg QC - 00630414599229

Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995599
In Commercial Distribution

  • 00630414599229 ()
10995599

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur® Systems HBeAg QC - 00630414531298

Hepatitis B e Antigen (HBeAg) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10338289
In Commercial Distribution

  • 00630414531298 ()
6981117

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur® Rub G QC - 00630414201429

Rubella IgG - CENTAUR - CONS - 3x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310284
In Commercial Distribution

  • 00630414201429 ()
117711

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

IMMULITE Systems Rubella Quantitative IgG CVM - 00630414973784

Rubella Quantitative IgG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388114
In Commercial Distribution

  • 00630414973784 ()
LRUBCVM

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

Atellica IM Rub G QC - 00630414600536

Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995671
In Commercial Distribution

  • 00630414600536 ()
10995671

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

Alinity - 00380740180973

Alinity i CMV IgG Controls
Abbott Ireland Diagnostics
07P4212
In Commercial Distribution

  • 00380740180973 ()
07P4212

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

EliA IgG Calibrators - 07333066020051

Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal-600) to form a complete calibration curve for EliA IgG method.
Phadia AB
83-1000-01
In Commercial Distribution

  • 07333066020051 ()
83-1000-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Specific IgG Conjugate 50 - 07333066019765

ImmunoCAP Specific IgG Conjugate 50
Phadia AB
34-2271-71
In Commercial Distribution

  • 07333066000770 ()
  • 07333066019765 ()
  • 07333066000190 ()
34-2271-71

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Specific IgG Curve Controls - 07333066019581

Contains three vials of each Specific IgG Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgG method.
Phadia AB
10-9333-01
In Commercial Distribution

  • 07333066019581 ()
10-9333-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Specific IgG Calibrators - 07333066019567

Contains one vial of each Specific IgG Calibrator (Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0, Cal-2.0) to form a complete calibration curve for the ImmunoCAP Specific IgG method.
Phadia AB
10-9305-01
In Commercial Distribution

  • 07333066019567 ()
10-9305-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Specific IgG Conjugate - 07333066019826

ImmunoCAP Specific IgG Conjugate
Phadia AB
34-2294-41
In Commercial Distribution

  • 07333066000503 ()
  • 07333066019826 ()
34-2294-41

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Calibrator Well - 07333066014609

EliA IgG Calibrator Well
Phadia AB
DECC055090
In Commercial Distribution

  • 07333066010649 ()
  • 07333066014609 ()
DECC055090

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Conjugate 200 - 07333066012827

EliA IgG Conjugate 200
Phadia AB
83-0003-21
In Commercial Distribution

  • 07333066013756 ()
  • 07333066012827 ()
83-0003-21

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Conjugate 50 - 07333066012810

EliA IgG Conjugate 50
Phadia AB
83-0003-11
In Commercial Distribution

  • 07333066013749 ()
  • 07333066012810 ()
83-0003-11

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Curve Control Strip - 07333066012803

EliA IgG Curve Control Strip
Phadia AB
83-0003-01
In Commercial Distribution

  • 07333066013732 ()
  • 07333066012803 ()
83-0003-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Calibrator Strip - 07333066012797

EliA IgG Calibrator Strip
Phadia AB
83-0002-91
In Commercial Distribution

  • 07333066013725 ()
  • 07333066012797 ()
83-0002-91

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Curve Control - 07333066012704

EliA IgG Curve Control
Phadia AB
83-0000-91
In Commercial Distribution

  • 07333066013633 ()
  • 07333066012704 ()
83-0000-91

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Conjugate - 07333066012629

EliA IgG Conjugate
Phadia AB
83-0000-11
In Commercial Distribution

  • 07333066013640 ()
  • 07333066012629 ()
  • 07333066013664 ()
83-0000-11

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Specific IgG Curve Control Strip - 07333066011615

ImmunoCAP Specific IgG Curve Control Strip
Phadia AB
34-2273-31
In Commercial Distribution

  • 07333066000305 ()
  • 07333066011615 ()
34-2273-31

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP Specific IgG Calibrator Strip - 07333066011585

ImmunoCAP Specific IgG Calibrator Strip
Phadia AB
34-2272-71
In Commercial Distribution

  • 07333066000237 ()
  • 07333066011585 ()
34-2272-71

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

ImmunoCAP IgA/IgG Calibrator ImmunoCAP - 07333066003740

ImmunoCAP IgA/IgG Calibrator ImmunoCAP
Phadia AB
14-4424-01
In Commercial Distribution

  • 07333066003740 ()
14-4424-01

  • Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

Tissue-Tek Genie® - 00615233008947

anti-IgG4 Mouse Monoclonal Antibody [HP6025], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8384-M250
In Commercial Distribution

  • 00615233008947 ()
8384-M250

  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Tissue-Tek Genie® - 00615233008930

anti-IgG4 Mouse Monoclonal Antibody [HP6025], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8384-C010
In Commercial Distribution

  • 00615233008930 ()
8384-C010

  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

Atellica IM CMV IgG - 00630414246635

CMV IgG Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202208
In Commercial Distribution

  • 00630414246635 ()
11202208

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Tetanus Toxoid IgG Low Control - 05051700019606

No Description
THE BINDING SITE GROUP LIMITED
EA116.L.A
In Commercial Distribution

  • 05051700019606 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, control

Tetanus Toxoid IgG High Control - 05051700019590

No Description
THE BINDING SITE GROUP LIMITED
EA116.A
In Commercial Distribution

  • 05051700019590 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, control

ImmunoDOT Borrelia Positive Control - 00613745039053

This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.
Genbio
800-3905
In Commercial Distribution

  • 00613745039053 ()

  • 0.1 mL
3905

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

Mouse IgG3 FITC Conjugate - 10190302009485

No Description
LIFE TECHNOLOGIES CORPORATION
MG301
In Commercial Distribution

  • 10190302009485 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control
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