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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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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)

ACCURUN® - 00816784020154

ACCURUN 30 EBV IgG 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0037
In Commercial Distribution

  • 00816784020154 ()
2000-0037

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

ACCURUN® - 00816784020475

ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0093
In Commercial Distribution

  • 00816784020475 ()

  • Total Volume: 6 Milliliter
2015-0093

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

ACCURUN® - 00816784020468

ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0092
In Commercial Distribution

  • 00816784020468 ()

  • Total Volume: 42 Milliliter
2015-0092

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

ACCURUN® - 00816784020451

ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0090
In Commercial Distribution

  • 00816784020451 ()
2015-0090

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

ACCURUN® - 00816784020376

ACCURUN 130 Borrelia burgdorferi IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0080
In Commercial Distribution

  • 00816784020376 ()
2015-0080

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

Helicobacter pylori control slides - B502BSB56090

Helicobacter pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB56090 ()
BSB 5609

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

Tinto Cathepsin K (BSB-172) - B502BSB380070

Tinto Cathepsin K 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.
BSB-3800-7
In Commercial Distribution

  • B502BSB380070 ()

  • Total Volume: 7 Milliliter
BSB-3800-7

  • Cathepsin IVD, antibody

Tinto Cathepsin K (BSB-172) - B502BSB380030

Tinto Cathepsin K 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.
BSB-3800-3
In Commercial Distribution

  • B502BSB380030 ()

  • Total Volume: 3 Milliliter
BSB-3800-3

  • Cathepsin IVD, antibody

Cathepsin K (BSB-172) - B502BSB380010

Cathepsin K 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.
BSB-3800-1
In Commercial Distribution

  • B502BSB380010 ()

  • Total Volume: 1 Milliliter
BSB-3800-1

  • Cathepsin IVD, antibody

Cathepsin K (BSB-172) - B502BSB3800050

Cathepsin K 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.
BSB-3800-05
In Commercial Distribution

  • B502BSB3800050 ()

  • Total Volume: 0.5 Milliliter
BSB-3800-05

  • Cathepsin IVD, antibody

Cathepsin K (BSB-172) - B502BSB3800010

Cathepsin K 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.
BSB-3800-01
In Commercial Distribution

  • B502BSB3800010 ()

  • Total Volume: 0.1 Milliliter
BSB-3800-01

  • Cathepsin IVD, antibody

Cathepsin K Control Slides - B502BSB9438CS0

Cathepsin K Control Slides
BIO SB, INC.
BSB-9438-CS
In Commercial Distribution

  • B502BSB9438CS0 ()
BSB-9438-CS

  • Cathepsin IVD, control

IgG4 Control Slides - B502BSB9237CS0

IgG4 Control Slides
BIO SB, INC.
BSB-9237-CS
In Commercial Distribution

  • B502BSB9237CS0 ()
BSB-9237-CS

  • Immunoglobulin G subclass (IgG subclass) IVD, control

IgG Control Slides - B502BSB9236CS0

IgG Control Slides
BIO SB, INC.
BSB-9236-CS
In Commercial Distribution

  • B502BSB9236CS0 ()
BSB-9236-CS

  • Immunoglobulin G subclass (IgG subclass) IVD, control

Helicobacter Pylori control slides - B502BSB32850

Helicobacter Pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB32850 ()
BSB 3285

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

Helicobacter Pylori control slides - B502BSB26830

Helicobacter Pylori Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB26830 ()
BSB 2683

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

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

VITROS - 10758750004546

VITROS Immunodiagnostic Products Rubella IgG Calibrators
ORTHO CLINICAL DIAGNOSTICS
8209074
In Commercial Distribution

  • 10758750004546 ()
8209074

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

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 - 08056771103008

No Description
DIASORIN SPA
310512
In Commercial Distribution

  • 08056771103008 ()
310512

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

LIAISON® CMV IgG - 08056771101905

No Description
DIASORIN SPA
310740
In Commercial Distribution

  • 08056771101905 ()


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

LIAISON® Control VCA IgG - 08056771101738

No Description
DIASORIN SPA
310511
In Commercial Distribution

  • 08056771101738 ()


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

LIAISON® Mumps IgG - 08056771101387

No Description
DIASORIN SPA
318840
In Commercial Distribution

  • 08056771101387 ()


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

LIAISON® Measles IgG - 08056771101325

No Description
DIASORIN SPA
318810
In Commercial Distribution

  • 08056771101325 ()


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

LIAISON® Control VZV IgG - 08056771100632

No Description
DIASORIN SPA
310496
In Commercial Distribution

  • 08056771100632 ()


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

Alinity - 00380740181109

Alinity i CMV IgG Reagent Kit (1000T)
Abbott Ireland Diagnostics
07P4233
In Commercial Distribution

  • 00380740181109 ()
07P4233

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

Alinity - 00380740181093

Alinity i CMV IgG Reagent Kit (200T)
Abbott Ireland Diagnostics
07P4224
In Commercial Distribution

  • 00380740181093 ()
07P4224

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

Mouse IgG3 FITC Conjugate - 10190302009485

No Description
LIFE TECHNOLOGIES CORPORATION
MG301
In Commercial Distribution

  • 10190302009485 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, control

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
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