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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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APO B - 05055273204346

An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.
RANDOX LABORATORIES LIMITED
LP2117
In Commercial Distribution

  • 05055273204346 ()
LP2117

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

Alinity - 00380740154509

Alinity c Apolipoprotein B Reagent Kit 190 Tests
Abbott GmbH
09P4720
In Commercial Distribution

  • 00380740154509 ()
09P4720

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

ARCHITECT - 00380740175146

Apolipoprotein B
Abbott GmbH
9D93-22
In Commercial Distribution

  • 00380740175146 ()
09D9322

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

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

Dimension Vista®Apolipoprotein B Flex® reagent cartridge - 00842768006029

For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445887
In Commercial Distribution

  • 00842768006029 ()
  • 00842768019906 ()
K7020

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

ADVIA® Chemistry APO B Reagents - 00630414517674

Apolipoprotein B - ADVIA Chem. - RGT - 2x85 tests
Siemens Healthcare Diagnostics Inc.
10318207
In Commercial Distribution

  • 00630414517674 ()
3055068

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

Atellica CH APO B - 00630414596235

Apolipoprotein B (APO B) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11097626
In Commercial Distribution

  • 00630414596235 ()
11097626

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

Human Apolipoprotein B (Apo B) kit for use on SPAPLUS - 05051700016889

No Description
THE BINDING SITE GROUP LIMITED
NK086.S
In Commercial Distribution

  • 05051700016889 ()


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

VITROS - 10758750006878

VITROS Chemistry Products ApoB Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801738
In Commercial Distribution

  • 10758750006878 ()
  • 20758750006875 ()
6801738

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

Tinaquant Apolipoprotein B ver2 - 04015630917754

No Description
Roche Diagnostics GmbH
3032639122
In Commercial Distribution

  • 04015630917754 ()
3032639122

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

Tinaquant Apolipoprotein B ver2 - 04015630917730

No Description
Roche Diagnostics GmbH
3032574122
In Commercial Distribution

  • 04015630917730 ()
3032574122

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

Tinaquant Apolipoprotein B ver2 - 04015630930234

No Description
Roche Diagnostics GmbH
6301711190
In Commercial Distribution

  • 04015630930234 ()
6301711190

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

Tinaquant Apolipoprotein B ver2 - 04015630928668

No Description
Roche Diagnostics GmbH
5950694190
In Commercial Distribution

  • 04015630928668 ()
5950694190

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

Tina-quant Apolipoprotein B ver.2 - 07613336133538

No Description
Roche Diagnostics GmbH
08105464190
In Commercial Distribution

  • 07613336133538 ()
08105464190

  • 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

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
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