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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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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
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
For the quantitative measurement of immunoglobulin G in human serum, plasma and cerebrospinal fluid (CSF) an urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445903
In Commercial Distribution

  • 00842768006180 ()
  • 00842768020094 ()
K7056

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
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
Fluorescein conjugated polyclonal goat antiserum to Human IgG,IgA, and IgM (polyvalent)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761162 ()
116202

  • Total immunoglobulin G (IgG total) IVD, control
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
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
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
Radial immunodiffusion plate package for human IgM
KENT LABORATORIES INC
1
In Commercial Distribution

  • B176103411 ()
103411

  • Total immunoglobulin M (IgM total) IVD, antibody
Radial immunodiffusion plate package for human human IgG with three standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761015 ()
101511

  • Total immunoglobulin G (IgG total) IVD, control
Radial immunodiffusion plate package for human IgG
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761014 ()
101411

  • Total immunoglobulin G (IgG total) IVD, control
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 Chemistry Products IgG Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801733
In Commercial Distribution

  • 10758750006823 ()
  • 20758750006820 ()
6801733

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
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 Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
Beckman Coulter, Inc.
447020
In Commercial Distribution

  • 15099590226985 ()
447020

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent
Beckman Coulter, Inc.
446400
In Commercial Distribution

  • 15099590223885 ()
446400

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
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 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 Immunochemistry Systems IGM Immunoglobulin M Reagent
Beckman Coulter, Inc.
447610
In Commercial Distribution

  • 15099590221195 ()
447610

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgM
Beckman Coulter, Inc.
OSR61173
In Commercial Distribution

  • 15099590011598 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgG
Beckman Coulter, Inc.
OSR61172
In Commercial Distribution

  • 15099590011581 ()


  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
IgA
Beckman Coulter, Inc.
OSR61171
In Commercial Distribution

  • 15099590011574 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Monoclonal Mouse Anti-Human Amyloid A Clone mc1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
M0759
In Commercial Distribution

  • 05700572005339 ()

  • Total Volume: 1 Milliliter


  • Amyloid A component IVD, antibody
NCL-L-SP-A is intended for the qualitative identification by light microscopy of human surfactant protein A in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
SP-A-L-U
In Commercial Distribution

  • 05055331321336 ()
NCL-L-SP-A

  • Surfactant apoprotein A IVD, antibody
FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Dako Omnis)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
GA605
In Commercial Distribution

  • 05700572034179 ()

  • Total Volume: 12 Milliliter


  • Amyloid A component IVD, antibody
FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IS605
In Commercial Distribution

  • 05700572030331 ()

  • 20-30 Tests


  • Amyloid A component IVD, antibody
FLEX Monoclonal Mouse Anti-Human Amyloid A Clone mc1 Ready-to-Use (Link)
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
IR605
In Commercial Distribution

  • 05700572030218 ()

  • 40-60 Tests


  • Amyloid A component IVD, antibody
No Description
Fisher Diagnostics
TR70121
In Commercial Distribution

  • 00845275003383 ()
  • 00845275006278 ()


  • Beta-hexosaminidase A (HexA) IVD, reagent
No Description
CHARMANT INC.
30-0702
In Commercial Distribution

  • 00883475953176 ()


  • Surgical A/V-shaped microvessel clamp
No Description
CHARMANT INC.
30-0701
In Commercial Distribution

  • 00883475953121 ()


  • Surgical A/V-shaped microvessel clamp
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