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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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Mouse IgG3 Purified Antibody - 10190302009478

No Description
LIFE TECHNOLOGIES CORPORATION
MG300
In Commercial Distribution

  • 10190302009478 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2b APC Conjugate - 10190302009461

No Description
LIFE TECHNOLOGIES CORPORATION
MG2B05
In Commercial Distribution

  • 10190302009461 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2b R-PE Conjugate - 10190302009454

No Description
LIFE TECHNOLOGIES CORPORATION
MG2B04
In Commercial Distribution

  • 10190302009454 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2b FITC Conjugate - 10190302009447

No Description
LIFE TECHNOLOGIES CORPORATION
MG2B01
In Commercial Distribution

  • 10190302009447 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2b Purified Antibody - 10190302009430

No Description
LIFE TECHNOLOGIES CORPORATION
MG2B00
In Commercial Distribution

  • 10190302009430 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a Pacific Orange™ Conjugate - 10190302009423

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A30
In Commercial Distribution

  • 10190302009423 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a APC-Alexa Fluor® 750 Conj. - 10190302009416

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A27
In Commercial Distribution

  • 10190302009416 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a Alexa Fluor® 488 Conjugate - 10190302009409

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A20
In Commercial Distribution

  • 10190302009409 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a PE-Cy®5.5 Conjugate - 10190302009393

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A18
Not in Commercial Distribution

  • 10190302009393 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a PE-Texas Red® Conjugate - 10190302009386

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A17
In Commercial Distribution

  • 10190302009386 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a TRI-COLOR® Conjugate - 10190302009379

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A06
In Commercial Distribution

  • 10190302009379 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a APC Conjugate - 10190302009362

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A05
In Commercial Distribution

  • 10190302009362 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a R-PE Conjugate - 10190302009355

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A04
In Commercial Distribution

  • 10190302009355 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a FITC Conjugate - 10190302009348

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A01
In Commercial Distribution

  • 10190302009348 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG2a Purified Antibody - 10190302009331

No Description
LIFE TECHNOLOGIES CORPORATION
MG2A00
In Commercial Distribution

  • 10190302009331 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 PerCP Conjugate - 10190302009324

No Description
LIFE TECHNOLOGIES CORPORATION
MG131
In Commercial Distribution

  • 10190302009324 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Pacific Orange™ Conjugate - 10190302009317

No Description
LIFE TECHNOLOGIES CORPORATION
MG130
In Commercial Distribution

  • 10190302009317 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Alexa Fluor® 700 Conjugate - 10190302009300

No Description
LIFE TECHNOLOGIES CORPORATION
MG129
In Commercial Distribution

  • 10190302009300 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Pacific Blue™ Conjugate - 10190302009294

No Description
LIFE TECHNOLOGIES CORPORATION
MG128
In Commercial Distribution

  • 10190302009294 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Alexa Fluor® 647 Conjugate - 10190302009287

No Description
LIFE TECHNOLOGIES CORPORATION
MG121
In Commercial Distribution

  • 10190302009287 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Alexa Fluor® 488 Conjugate - 10190302009270

No Description
LIFE TECHNOLOGIES CORPORATION
MG120
In Commercial Distribution

  • 10190302009270 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 PE-Cy® 5.5 Conjugate - 10190302009263

No Description
LIFE TECHNOLOGIES CORPORATION
MG118
In Commercial Distribution

  • 10190302009263 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 PE-Texas Red® Conjugate - 10190302009256

No Description
LIFE TECHNOLOGIES CORPORATION
MG117
In Commercial Distribution

  • 10190302009256 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Biotin Conjugate - 10190302009249

No Description
LIFE TECHNOLOGIES CORPORATION
MG115
In Commercial Distribution

  • 10190302009249 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 PE-Cy®7 Conjugate - 10190302009232

No Description
LIFE TECHNOLOGIES CORPORATION
MG112
In Commercial Distribution

  • 10190302009232 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 TRI-COLOR® Conjugate - 10190302009225

No Description
LIFE TECHNOLOGIES CORPORATION
MG106
In Commercial Distribution

  • 10190302009225 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 APC Conjugate - 10190302009218

No Description
LIFE TECHNOLOGIES CORPORATION
MG105
In Commercial Distribution

  • 10190302009218 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 R-PE Conjugate - 10190302009201

No Description
LIFE TECHNOLOGIES CORPORATION
MG104
In Commercial Distribution

  • 10190302009201 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 FITC Conjugate - 10190302009195

No Description
LIFE TECHNOLOGIES CORPORATION
MG101
In Commercial Distribution

  • 10190302009195 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Mouse IgG1 Purified Antibody - 10190302009188

No Description
LIFE TECHNOLOGIES CORPORATION
MG100
In Commercial Distribution

  • 10190302009188 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

Trinity Biotech - 05391516748810

Uni-Gold™ S. pneumoniae, 20 Tests
MARDX DIAGNOSTICS, INC.
1204420
In Commercial Distribution

  • 05391516748810 ()
1204420

  • Streptococcus pneumoniae immunoglobulin G (IgG) antibody IVD, kit, multiplex

IFA Measles IgG Test System - 00845533001632

The ZEUS IFA Measles IgG Test System is designed for the qualitative and quantitative detection of Measles antibody in human serum by the indirect fluorescent antibody (IFA) technique. The assay can determine or confirm recent infection or immune status and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9251G
In Commercial Distribution

  • 00845533001632 ()
FA9251G

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

IFA CMV IgG Test System - 00845533001533

The ZEUS IFA Cytomegalovirus (CMV) IgG Test System is designed for the qualitative and semi-quantitative detection of anti-CMV IgG antibody in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
ZEUS SCIENTIFIC, INC.
FA9001G
In Commercial Distribution

  • 00845533001533 ()
FA9001G

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

Adenovirus IgG ELISA - 00404847434460

The DRG Adenovirus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Adenovirus in serum. This assay is intended for in vitro diagnostic use only.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3446
Not in Commercial Distribution

  • 00404847434460 ()
EIA-3446

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

Pseudomonas-CF-IgG standard control serum - 05713106609002

Human-antisera, Pseudomonas-CF-IgG
Ssi Diagnostica A/S
60900
Not in Commercial Distribution

  • 05713106609002 ()
60900

  • Pseudomonas aeruginosa immunoglobulin G (IgG) antibody IVD, control

Cytomegalovirus / CMV IgG IFA 96 Test - G5229021111

For the detection and titration of cytomegalovirus (CMV) IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902111
In Commercial Distribution

  • G5229021111 ()


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

West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control - 10816101022332

No Description
DIASORIN MOLECULAR LLC
EL0311
In Commercial Distribution

  • 10816101022332 ()
EL0311

  • West Nile virus immunoglobulin G (IgG) antibody IVD, control

Elecsys CMV IgG - 04015630940172

No Description
Roche Diagnostics GmbH
07027117190
In Commercial Distribution

  • 04015630940172 ()
07027117190

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

Elecsys CMV IgG Assay - 04015630937172

No Description
Roche Diagnostics GmbH
7309325160
In Commercial Distribution

  • 04015630937172 ()
7309325160

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

Adenovirus IgG ELISA - 00840239034465

The DRG Adenovirus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Adenovirus in serum
DRG International Inc
EIA-3446
In Commercial Distribution

  • 00840239034465 ()
EIA-3446

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

VITROS - 10758750004997

VITROS Immunodiagnostic Products Rubella IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
8536195
In Commercial Distribution

  • 10758750004997 ()
8536195

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

CHORUS ADENOVIRUS IgG - 08033891327606

No Description
DIESSE DIAGNOSTICA SENESE SPA
81196
In Commercial Distribution

  • 08033891327606 ()
81196

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

BioPlex 2200 - 03610520653005

BioPlex 2200 Syphilis Total & RPR Control Lot Data
BIO-RAD LABORATORIES, INC.
12000654
In Commercial Distribution

  • 03610520653005 ()

  • 1 Each
12000654

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control

BioPlex 2200 - 03610520652794

BioPlex 2200 Syphilis Total & RPR Control Set
BIO-RAD LABORATORIES, INC.
12000653
In Commercial Distribution

  • 03610520652794 ()

  • 6 Vials
  • Total Volume: 1.5 Milliliter
12000653

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control

LIAISON® H. pylori IgG Control Set - 08056771602051

No Description
Diasorin Inc.
318981
In Commercial Distribution

  • 08056771602051 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

LIAISON® VCA IgG Serum Control Set - 08056771601771

No Description
DIASORIN SPA
310512
Not in Commercial Distribution

  • 08056771601771 ()


  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

LIAISON® Control Borrelia burgdorferi - 08056771600279

No Description
Diasorin Inc.
310871
In Commercial Distribution

  • 08056771600279 ()


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

LIAISON® Control VZV IgG HT - 08056771104173

No Description
DIASORIN SPA
311871
In Commercial Distribution

  • 08056771104173 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control

LIAISON® VZV IgG HT - 08056771104166

No Description
DIASORIN SPA
311870
In Commercial Distribution

  • 08056771104166 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

LIAISON® Biotrin Parvovirus B19 IgG Plus - 08056771104029

Italy manufactured kit.
DIASORIN SPA
311550
In Commercial Distribution

  • 08056771104029 ()


  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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