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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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ARCHITECT - 00380740175139

Apolipoprotein A1
Abbott GmbH
9D92-22
In Commercial Distribution

  • 00380740175139 ()
09D9222

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry APO A1 Reagents - 00630414517636

Apolipoprotein A1 - ADVIA Chem. - RGT - 2x75 tests
Siemens Healthcare Diagnostics Inc.
10318196
In Commercial Distribution

  • 00630414517636 ()
3050910

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS - 05051700016872

No Description
THE BINDING SITE GROUP LIMITED
NK085.S
In Commercial Distribution

  • 05051700016872 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Atellica CH APO A1 - 00630414596242

Apolipoprotein A-1 (APO A1) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11097625
In Commercial Distribution

  • 00630414596242 ()
11097625

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein A-I - 00842768011269

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446438
In Commercial Distribution

  • 00842768011269 ()
OUED15

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein A-I - 00842768011252

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446437
In Commercial Distribution

  • 00842768011252 ()
OUED09

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Dimension Vista® Apolipoprotein AI Flex® reagent cartridge - 00842768006012

For the quantitative measurement of apolipoprotein A-I in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445886
In Commercial Distribution

  • 00842768006012 ()
  • 00842768019890 ()
K7018

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Tina-quant Apolipoprotein A-1 ver.2 - 07613336133521

No Description
Roche Diagnostics GmbH
08105448190
In Commercial Distribution

  • 07613336133521 ()
08105448190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Diazyme - 00817089020016

No Description
DIAZYME LABORATORIES, INC.
DZ141A-K
In Commercial Distribution

  • 00817089020016 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632 - 00817302020885

APO A1 (Apolipoprotein A1) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-632
Not in Commercial Distribution

  • 00817302020885 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 46 Milliliter
  • Total Volume: 16 Milliliter
AU-632

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632 - 00817302020878

APO A1 (Apolipoprotein A1) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL632
Not in Commercial Distribution

  • 00817302020878 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 23 Milliliter
BL632

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Synchron - 15099590229931

Apolipoprotein A Reagent (ApoA 2 x 100)
Beckman Coulter, Inc.
467900
In Commercial Distribution

  • 15099590229931 ()
467900

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

AU - 15099590010393

APO A1
Beckman Coulter, Inc.
OSR6142
In Commercial Distribution

  • 15099590010393 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590223878

IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent
Beckman Coulter, Inc.
446410
In Commercial Distribution

  • 15099590223878 ()
446410

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006700

VITROS Chemistry Products Calibrator Kit 22
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801706
In Commercial Distribution

  • 10758750006700 ()
6801706

  • Apolipoprotein A-I (Apo A1) IVD, calibrator

N/A - 00810047420804

Crypto Kinyoun Decolorizer [250ml x 6 bottles/pkg]
Scientific Device Laboratory, Inc.
379-B
In Commercial Distribution

  • 00810047420804 ()


  • Biological stain IVD

TRITON - 00859506006081

Triton AI Calibration Placard
STRYKER CORPORATION
FG-12008
In Commercial Distribution

  • 00859506006081 ()
  • 10859506006088 ()
FG-12008

  • Blood loss estimation canister insert/label

Medline Industries, Inc. - 10193489947168

HEART AI VASCULAR TRAY
MEDLINE INDUSTRIES, INC.
DYNJ69470
In Commercial Distribution

  • 10193489947168 ()
  • 40193489947169 ()
DYNJ69470

  • General surgical procedure kit, non-medicated, single-use

Caption - 00198953030233

Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software

ARCHITECT - 00380740019716

Apolipoprotein A1
ABBOTT LABORATORIES
9D92-21
In Commercial Distribution

  • 00380740019716 ()
09D9221

  • Apolipoprotein A-I (Apo A1) IVD, reagent
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