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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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ORTHO VERSEIA™ Pipetter Workstation - computer
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842852
In Commercial Distribution

  • 10758750011582 ()
6842852

  • Enzyme immunoassay (EIA) analyser IVD
Auto Reader IV
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902093
In Commercial Distribution

  • 10758750007523 ()
6902093

  • Microplate reader IVD, automated/semi-automated
FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
ALBA BIOSCIENCE LIMITED
Z488
In Commercial Distribution

  • 10758750006144 ()


  • Foeto-maternal haemorrhage/Kleihauer test IVD, control
Ortho Summit Processor (OSP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936480
In Commercial Distribution

  • 10758750005581 ()
936480

  • Enzyme immunoassay (EIA) analyser IVD
OAS Server - 450 MHz, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416F
In Commercial Distribution

  • 10758750005505 ()
936416F

  • Laboratory instrument/analyser application software IVD
OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution

  • 10758750005499 ()
936416

  • Laboratory instrument/analyser application software IVD
OAS 400 MHz Workstation Refurbished for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936415F
In Commercial Distribution

  • 10758750005482 ()
936415F

  • Laboratory instrument/analyser application software IVD
OSP Workstation, 166 MHz (computer)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936396
In Commercial Distribution

  • 10758750005451 ()
936396

  • Enzyme immunoassay (EIA) analyser IVD
AutoWash 96, SLT/AutoWash 96, SLT, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
936380F
In Commercial Distribution

  • 10758750005420 ()
936380F

  • Microplate washer IVD
Incubator, KVM Model 120, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
934090F
In Commercial Distribution

  • 10758750005352 ()
934090F

  • Microplate/tube/assay card incubator IVD
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