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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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IMMAGE - 15099590224035

IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent
Beckman Coulter, Inc.
447730
In Commercial Distribution

  • 15099590224035 ()
447730

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

Synchron - 15099590231637

Apolipoprotein B Reagent (ApoB 2 x 100)
Beckman Coulter, Inc.
467905
In Commercial Distribution

  • 15099590231637 ()
467905

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

AU - 15099590010409

APO B
Beckman Coulter, Inc.
OSR6143
In Commercial Distribution

  • 15099590010409 ()


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

Diazyme - 90817089020002

No Description
DIAZYME LABORATORIES, INC.
DZ142A-K
In Commercial Distribution

  • 90817089020002 ()


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

CAROLINA LIQUID CHEMISTRIES CORP.® APO B REAGENT CC633 - 00817302020915

APO B (Apolipoprotein B) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC633
Not in Commercial Distribution

  • 00817302020915 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 23 Milliliter
CC633

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

CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633 - 00817302020908

APO B (Apolipoprotein B) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-633
In Commercial Distribution

  • 00817302020908 ()

  • Total Volume: 16 Milliliter
  • Total Volume: 46 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
AU-633

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

CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633 - 00817302020892

APO B (Apolipoprotein B) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL633
Not in Commercial Distribution

  • 00817302020892 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 23 Milliliter
BL633

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

VITROS - 10758750006694

VITROS Chemistry Products Calibrator Kit 21
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801705
In Commercial Distribution

  • 10758750006694 ()
6801705

  • Apolipoprotein B (Apo B) IVD, calibrator

ARCHITECT - 00380740019723

Apolipoprotein B
ABBOTT LABORATORIES
9D93-21
In Commercial Distribution

  • 00380740019723 ()
09D9321

  • Apolipoprotein B (Apo B) IVD, reagent

ARCHITECT - 00380740170165

Apolipoprotein B 243 tests
ABBOTT IRELAND
09D9324
In Commercial Distribution

  • 00380740170165 ()
09D9324

  • Apolipoprotein B (Apo B) IVD, reagent
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