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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 - 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

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

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
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