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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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Mumps IgG Test System, 120 Tests - B110MUG1200

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

  • B110MUG1200 ()
MUG-120

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

Mycoplasma pneumoniae IgG Control - B110MPG12200

No Description
Bion Enterprises, Ltd.
MPG-1220
In Commercial Distribution

  • B110MPG12200 ()
MPG-1220

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control

Measles IgG Test System, 120 Tests - B110MEG1200

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

  • B110MEG1200 ()
MEG-120

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

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

ANTI-CATHEPSIN D - 00810119678362

No Description
BIOGENEX LABORATORIES
AM467-5M
In Commercial Distribution

  • 00810119678362 ()

  • Total Volume: 6 Milliliter
AM467-5M

  • Cathepsin IVD, antibody

ANTI-Cathepsin D - 00810119674272

No Description
BIOGENEX LABORATORIES
MU961-5UC
In Commercial Distribution

  • 00810119674272 ()

  • Total Volume: 0.5 Milliliter
MU961-5UC

  • Cathepsin IVD, antibody

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

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

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

Mumps 10 Well; 10 pk - 00813545026059

No Description
SCIMEDX CORPORATION
I-MUV01X
In Commercial Distribution

  • 00813545026059 ()
I-MUV01X

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

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 10 Well; 10 pk - 00813545026028

No Description
SCIMEDX CORPORATION
I-MEA01X
In Commercial Distribution

  • 00813545026028 ()
I-MEA01X

  • Measles 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

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

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT - B126KR60150

A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR6015
In Commercial Distribution

  • B126KR60150 ()
KR6015

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

STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT - B126KR60100

A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR6010
In Commercial Distribution

  • B126KR60100 ()
KR6010

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

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

Mumps IgG IFA Slide Only Kit - G5229032011

For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
903201
In Commercial Distribution

  • G5229032011 ()


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

Mumps IgG IFA 96 Test - G5229032001

For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
903200
In Commercial Distribution

  • G5229032001 ()


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