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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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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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