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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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Roche Diagnostics GmbH
6301703190
In Commercial Distribution

  • 04015630930227 ()
6301703190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
5950686190
In Commercial Distribution

  • 04015630928651 ()
5950686190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
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
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
No Description
Roche Diagnostics GmbH
08105448190
In Commercial Distribution

  • 07613336133521 ()
08105448190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Alinity c Apolipoprotein A1 Reagent Kit 190 Tests
Abbott GmbH
09P4620
In Commercial Distribution

  • 00380740153908 ()
09P4620

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
Apolipoprotein A1
Abbott GmbH
9D92-22
In Commercial Distribution

  • 00380740175139 ()
09D9222

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
VITROS Chemistry Products Calibrator Kit 22
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801706
In Commercial Distribution

  • 10758750006700 ()
6801706

  • Apolipoprotein A-I (Apo A1) IVD, calibrator
HEART AI VASCULAR TRAY
MEDLINE INDUSTRIES, INC.
DYNJ69470
In Commercial Distribution

  • 10193489947168 ()
  • 40193489947169 ()
DYNJ69470

  • General surgical procedure kit, non-medicated, single-use
Triton AI Calibration Placard
STRYKER CORPORATION
FG-12008
In Commercial Distribution

  • 00859506006081 ()
  • 10859506006088 ()
FG-12008

  • Blood loss estimation canister insert/label
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