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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 Antithrombin III - 00842768009914

Quantitative determination of antithrombin III in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446310
In Commercial Distribution

  • 00842768009914 ()
OSAY09

  • Antithrombin III (ATIII) IVD, reagent

N Antiserum to Human Apolipoprotein B - 00842768009686

Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446287
In Commercial Distribution

  • 00842768009686 ()
OSAN15

  • Apolipoprotein B (Apo B) 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

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

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 - 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
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