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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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N Antiserum to Human Apolipoprotein B - 00842768009679

Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446286
In Commercial Distribution

  • 00842768009679 ()
OSAN09

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

N Latex IgM - 00842768007194

Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446035
In Commercial Distribution

  • 00842768007194 ()
OQAC11

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin M Flex® reagent cartridge - 00842768006197

For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445904
In Commercial Distribution

  • 00842768006197 ()
  • 00842768020100 ()
K7058

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin A Flex® reagent cartridge - 00842768006166

For the quantitative measurement of immunoglobulin A in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445901
In Commercial Distribution

  • 00842768006166 ()
  • 00842768020070 ()
K7052

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IGA_2 Reagents - 00630414513133

IgA - ADVIA Chem. - RGT - 5x75 tests
Siemens Healthcare Diagnostics Inc.
10309033
In Commercial Distribution

  • 00630414513133 ()
2194102

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry IGM_2 Reagents - 00630414513126

IgM - ADVIA Chem. - RGT - 4x90 tests
Siemens Healthcare Diagnostics Inc.
10309032
In Commercial Distribution

  • 00630414513126 ()
2193483

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

N Latex IgM - 00630414285023

Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873688
In Commercial Distribution

  • 00630414285023 ()
OQAC15

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Atellica CH IgM_2 - 00630414595627

Immunoglobulin M ( IgM_2) Atellica CH - RGT 720T
Siemens Healthcare Diagnostics Inc.
11097620
In Commercial Distribution

  • 00630414595627 ()
11097620

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Atellica CH IgA_2 - 00630414595610

Immunoglobulin A (IgA_2) Atellica CH - RGT 600T
Siemens Healthcare Diagnostics Inc.
11097619
In Commercial Distribution

  • 00630414595610 ()
11097619

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgA2 Kit - 05051700017664

No Description
THE BINDING SITE GROUP LIMITED
LK088.OPT.A
In Commercial Distribution

  • 05051700017664 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgA1 Kit - 05051700017657

No Description
THE BINDING SITE GROUP LIMITED
NK087.OPT.A
In Commercial Distribution

  • 05051700017657 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgM Kit - 05051700017565

No Description
THE BINDING SITE GROUP LIMITED
NK012.OPT.A
In Commercial Distribution

  • 05051700017565 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Human IgA kit for use on SPAPLUS- Bulk Kit - 05051700016742

No Description
THE BINDING SITE GROUP LIMITED
NK010.10S
In Commercial Distribution

  • 05051700016742 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Human IgM CSF Kit for use on SPAPLUS - 05051700016179

No Description
THE BINDING SITE GROUP LIMITED
LK012.L.S
Not in Commercial Distribution

  • 05051700016179 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Human IgA CSF Kit for use on SPAPLUS - 05051700016162

No Description
THE BINDING SITE GROUP LIMITED
LK010.L.S
Not in Commercial Distribution

  • 05051700016162 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA2 Kit for use on SPAPLUS - 05051700012324

No Description
THE BINDING SITE GROUP LIMITED
LK088.S
Not in Commercial Distribution

  • 05051700012324 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA1 Kit SPAplus - 05051700012317

No Description
THE BINDING SITE GROUP LIMITED
NK087.S
Not in Commercial Distribution

  • 05051700012317 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA Liquid Reagent Kit for use on SPAPLUS - 05051700012232

No Description
THE BINDING SITE GROUP LIMITED
NK010.S
Not in Commercial Distribution

  • 05051700012232 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Human IgA1 Subclass BNII Kit - 05051700007801

No Description
THE BINDING SITE GROUP LIMITED
NK087.1T
In Commercial Distribution

  • 05051700007801 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II - 05051700006538

No Description
THE BINDING SITE GROUP LIMITED
LK088.1T
In Commercial Distribution

  • 05051700006538 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II - 05051700006095

No Description
THE BINDING SITE GROUP LIMITED
LK003.T
In Commercial Distribution

  • 05051700006095 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgA CSF Kit - 05051700020190

No Description
THE BINDING SITE GROUP LIMITED
LK010.L.OPT.A
In Commercial Distribution

  • 05051700020190 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgM CSF Kit - 05051700020183

No Description
THE BINDING SITE GROUP LIMITED
LK012.L.OPT.A
In Commercial Distribution

  • 05051700020183 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Optilite IgA Kit - 05051700017701

No Description
THE BINDING SITE GROUP LIMITED
NK010.OPT.A
In Commercial Distribution

  • 05051700017701 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006830

VITROS Chemistry Products IgM Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801734
In Commercial Distribution

  • 10758750006830 ()
  • 20758750006837 ()
6801734

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006816

VITROS Chemistry Products IgA Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801732
In Commercial Distribution

  • 10758750006816 ()
  • 20758750006813 ()
6801732

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Immunoglobulin M - 04015630913725

No Description
Roche Diagnostics GmbH
20737771322
In Commercial Distribution

  • 04015630913725 ()
20737771322

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

C-3 (b1c/b1a) RID plate kit - B1761055

Radial immunodiffusion plate package for Human C-3 (b1c/b1a) with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761055 ()
105511

  • Complement components C3/C3c IVD, antibody

C-3 (b1c/b1a) RID Plate package - B1761054

Radial immunodiffusion plate package for Human C-3 (b1c/b1a)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761054 ()
105411

  • Complement components C3/C3c IVD, antibody

IgM RID plate kit - B1761035

Radial immunodiffusion plate package for human IgM with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761035 ()
103511

  • Total immunoglobulin M (IgM total) IVD, antibody

IgM RID plate package - B176103411

Radial immunodiffusion plate package for human IgM
KENT LABORATORIES INC
1
In Commercial Distribution

  • B176103411 ()
103411

  • Total immunoglobulin M (IgM total) IVD, antibody

IMMAGE - 15099590230470

IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent
Beckman Coulter, Inc.
446460
In Commercial Distribution

  • 15099590230470 ()
446460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590221225

IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A
Beckman Coulter, Inc.
447460
In Commercial Distribution

  • 15099590221225 ()
447460

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590221218

IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M
Beckman Coulter, Inc.
447470
In Commercial Distribution

  • 15099590221218 ()
447470

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590221195

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
447610
In Commercial Distribution

  • 15099590221195 ()
447610

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

AU - 15099590011598

IgM
Beckman Coulter, Inc.
OSR61173
In Commercial Distribution

  • 15099590011598 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

AU - 15099590011574

IgA
Beckman Coulter, Inc.
OSR61171
In Commercial Distribution

  • 15099590011574 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

SeraQuest - 00850487007609

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007609 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007043

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Syphilis G
In Commercial Distribution

  • 00850487007043 ()
Q01-580

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747967

B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G/B-A
In Commercial Distribution

  • 05391516747967 ()
40-5065G/B-A

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516747608

B. burgdorferi 10 Well Slides, 10 each pack
MARDX DIAGNOSTICS, INC.
32-5010
In Commercial Distribution

  • 05391516747608 ()
32-5010

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

MarDx - 05391516746625

Borrelia burgdorferi EIA IgG
CLARK LABORATORIES, INC.
40-8696G
In Commercial Distribution

  • 05391516746625 ()

  • 96 Tests
40-8696G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746267

B. burgdorferi EIA (IgG) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696G
In Commercial Distribution

  • 05391516746267 ()
40-8696G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746236

B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G/B
In Commercial Distribution

  • 05391516746236 ()
40-5065G/B

  • Borrelia garinii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746229

B. burgdorferi (IgG) Marblot Strip Test System (50 Tests)
MARDX DIAGNOSTICS, INC.
40-5065G
In Commercial Distribution

  • 05391516746229 ()
40-5065G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516746205

B. burgdorferi (IgG) Marblot Strip Test System (20 Tests)
MARDX DIAGNOSTICS, INC.
40-2075G
In Commercial Distribution

  • 05391516746205 ()
40-2075G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516744836

CAPTIA™ Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-960
In Commercial Distribution

  • 05391516744836 ()

  • 960 Tests
800-960

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech - 05391516744829

CAPTIA™Syphilis (T. Pallidum)-G
CLARK LABORATORIES, INC.
800-970
In Commercial Distribution

  • 05391516744829 ()

  • 96 Tests
800-970

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgG Smart Kit Test System - 00845533000185

The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG antibodies to Borrelia burgdorferi in human serum. This test should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
SM3Z9651G
In Commercial Distribution

  • 00845533000185 ()
SM3Z9651G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA B. burgdorferi IgG Test System - 00845533000178

The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG antibodies to Borrelia burgdorferi in human serum. This test should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
3Z9651G
In Commercial Distribution

  • 00845533000178 ()
3Z9651G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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