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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 - 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

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

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

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)

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

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

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

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 - B502BSB56090

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

  • B502BSB56090 ()
BSB 5609

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

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

Mumps IgG 120 Test Kit - 00813545026035

No Description
SCIMEDX CORPORATION
I-MUV01G
In Commercial Distribution

  • 00813545026035 ()
I-MUV01G

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

Measles IgG 120 Test Kit - 00813545026004

No Description
SCIMEDX CORPORATION
I-MEA01G
In Commercial Distribution

  • 00813545026004 ()
I-MEA01G

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

Cytomegalovirus IgG 120 Tests - 00813545025489

No Description
SCIMEDX CORPORATION
I-CMV01G
In Commercial Distribution

  • 00813545025489 ()
I-CMV01G

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

Varicella Zoster IgG Control - B110VZG70200

No Description
Bion Enterprises, Ltd.
VZG-7020
In Commercial Distribution

  • B110VZG70200 ()
VZG-7020

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

EBNA Positive Control - B110NA51400

No Description
Bion Enterprises, Ltd.
NA-5140
Not in Commercial Distribution

  • B110NA51400 ()
NA-5140

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

Influenza B Negative Control - B110IBN21100

No Description
Bion Enterprises, Ltd.
IBN-2110
In Commercial Distribution

  • B110IBN21100 ()
IBN-2110

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control

Influenza B IgG Control - B110IBG21200

No Description
Bion Enterprises, Ltd.
IBG-2120
In Commercial Distribution

  • B110IBG21200 ()
IBG-2120

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, control

Influenza A Negative Control - B110IAN11100

No Description
Bion Enterprises, Ltd.
IAN-1110
In Commercial Distribution

  • B110IAN11100 ()
IAN-1110

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control

Influenza A IgG Control - B110IAG11200

No Description
Bion Enterprises, Ltd.
IAG-1120
In Commercial Distribution

  • B110IAG11200 ()
IAG-1120

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, control

EBV IgG Control - B110EBG50200

No Description
Bion Enterprises, Ltd.
EBG-5020
In Commercial Distribution

  • B110EBG50200 ()
EBG-5020

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

CMV IgG Test System, 120 Tests - B110CMG1200

No Description
Bion Enterprises, Ltd.
CMG-120
In Commercial Distribution

  • B110CMG1200 ()
CMG-120

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

Borrelia IgG Control - B110BBG61200

No Description
Bion Enterprises, Ltd.
BBG-6120
In Commercial Distribution

  • B110BBG61200 ()
BBG-6120

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

KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAb) RIA ASSAY KIT - B126KR75900

A radioimmunoassay for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor (AChR) in human serum.
KRONUS, INC.
KR7590
In Commercial Distribution

  • B126KR75900 ()
KR7590

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT - B126KR67550

A radioimmunoassay for the semi-quantitative determination of antibodies to tyrosine phosphatase (IA-2) in human serum.
KRONUS, INC.
KR6755
In Commercial Distribution

  • B126KR67550 ()
KR6755

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay
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