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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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ADVIA Centaur® iPTH Calibrator - 00630414587486

PTH intact - CENTAUR - CAL 56 - 6 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630628
In Commercial Distribution

  • 00630414587486 ()
10630628

  • Parathyroid hormone (PTH) IVD, calibrator

Dimension Vista® CHEM 1 CAL - 00630414948508

Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL)
Siemens Healthcare Diagnostics Inc.
10716281
Not in Commercial Distribution

  • 00630414948508 ()
KC110B

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Liquichek - 00847661004516

Liquichek D-dimer Control MiniPak (A processed human plasma assayed D-dimer control.)
BIO-RAD LABORATORIES, INC.
27102X
In Commercial Distribution

  • 00847661004516 ()
27102X

  • D-dimer IVD, control

Liquichek - 00847661004509

Liquichek D-dimer Control Level 3 (A processed human plasma assayed D-dimer control.)
BIO-RAD LABORATORIES, INC.
27103
In Commercial Distribution

  • 00847661004509 ()
27103

  • D-dimer IVD, control

Liquichek - 00847661004493

Liquichek D-dimer Control Level 2 (A processed human plasma assayed D-dimer control.)
BIO-RAD LABORATORIES, INC.
27102
In Commercial Distribution

  • 00847661004493 ()
27102

  • D-dimer IVD, control

Liquichek - 00847661004486

Liquichek D-dimer Control Level 1 (A processed human plasma assayed D-dimer control.)
BIO-RAD LABORATORIES, INC.
27101
In Commercial Distribution

  • 00847661004486 ()
27101

  • D-dimer IVD, control

Liquichek - 00847661004479

Liquichek D-dimer Control Level Low (A processed human plasma assayed D-dimer control.)
BIO-RAD LABORATORIES, INC.
27100
In Commercial Distribution

  • 00847661004479 ()
27100

  • D-dimer IVD, control

Liquichek - 00847661001836

Liquichek Rheumatoid Factor Control MiniPalk (A human serum assayed rheumatoid factor control.)
BIO-RAD LABORATORIES, INC.
502X
In Commercial Distribution

  • 00847661001836 ()
502X

  • Rheumatoid factor IVD, control

Liquichek - 00847661001515

Liquichek Rheumatoid Factor Control Level 3 (A human serum assayed rheumatoid factor control.)
BIO-RAD LABORATORIES, INC.
503
In Commercial Distribution

  • 00847661001515 ()
503

  • Rheumatoid factor IVD, control

Liquichek - 00847661001508

Liquichek Rheumatoid Factor Control Level 2 (A human serum assayed rheumatoid factor control.)
BIO-RAD LABORATORIES, INC.
502
In Commercial Distribution

  • 00847661001508 ()
502

  • Rheumatoid factor IVD, control
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