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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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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

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 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

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

LIAISON® VZV IgG - 08056771100625

No Description
DIASORIN SPA
310495
In Commercial Distribution

  • 08056771100625 ()


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

LIAISON® Rubella IgG - 08056771100571

No Description
DIASORIN SPA
310460
In Commercial Distribution

  • 08056771100571 ()


  • 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® Control Borrelia burgdorferi - 08056771600279

No Description
Diasorin Inc.
310871
In Commercial Distribution

  • 08056771600279 ()


  • Borrelia burgdorferi 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

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

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

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

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

Elecsys CMV IgG - 07613336198469

No Description
Roche Diagnostics GmbH
09118551190
In Commercial Distribution

  • 07613336198469 ()
09118551190

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

Elecsys CMV IgG - 07613336193082

No Description
Roche Diagnostics GmbH
09338977160
In Commercial Distribution

  • 07613336193082 ()
09338977160

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

Elecsys Anti-CMV - 07613336183069

No Description
Roche Diagnostics GmbH
09118551162
In Commercial Distribution

  • 07613336228449 ()
  • 07613336183069 ()
09118551162

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