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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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Alinity - 00380740155360

Alinity I Intact PTH Calibrators
Abbott GmbH
08P3102
In Commercial Distribution

  • 00380740155360 ()
08P3102

  • Parathyroid hormone (PTH) IVD, calibrator

IMMULITE® 2000 TSI CVM - 00630414006680

IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control

IMMULITE Systems Total Testosterone CVM - 00630414979465

Testosterone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388170
In Commercial Distribution

  • 00630414979465 ()
LTWCVM

  • Total testosterone IVD, control

IMMULITE® Systems DHS Calibration Verification Material DHEA-SO4 - 00630414979373

HCG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387935
In Commercial Distribution

  • 00630414979373 ()
LDSCVM

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control

IMMULITE® Systems ACT ACTH Calibration Verification Material - 00630414979366

ACTH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387863
In Commercial Distribution

  • 00630414979366 ()
LACCVM

  • Adrenocorticotropic hormone (ACTH) IVD, control

IMMULITE® 3RD GEN. PSA CVM - 00630414601939

3rd Generation PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713725
In Commercial Distribution

  • 00630414601939 ()
L3PSCVM

  • Total prostate specific antigen (tPSA) IVD, control

Kallestad - 00847865001724

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26115
In Commercial Distribution

  • 00847865001724 ()

  • 8 Well
  • 160 Tests
26115

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001717

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26112
In Commercial Distribution

  • 00847865001717 ()

  • 8 Well
  • 800 Tests
26112

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001700

Kallestad Mouse Stomach/Kidney 8 Well Slides
Bio-RAD Laboratories, Inc.
26111
In Commercial Distribution

  • 00847865001700 ()

  • 48 Tests
  • 8 Well
26111

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

Kallestad - 00847865001571

Kallestad Crithidia luciliae 8 Well Slides
Bio-RAD Laboratories, Inc.
26110
In Commercial Distribution

  • 00847865001571 ()

  • 160 Tests
  • 8 Wells
26110

  • Native DNA antibody (anti-nDNA) IVD, reagent
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