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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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IMMULITE® Systems HCG Calibration Verification Material HCG - 00630414973562

HCG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387900
In Commercial Distribution

  • 00630414973562 ()
LCGCVM

  • Total human chorionic gonadotropin IVD, control

IMMULITE Systems Beta-2 Microglobulin CVM - 00630414973555

Beta-2 Microglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387885
In Commercial Distribution

  • 00630414973555 ()
LBMCVM

  • Beta-2-microglobulin IVD, control

IMMULITE® 2000 Systems Diluent Tubes - 00630414973159

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385210
In Commercial Distribution

  • 00630414973159 ()
L2ZT

  • General specimen container IVD, no additive/medium

IMMULITE®2000 Systems Diluent Tube Caps - 00630414972923

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385211
In Commercial Distribution

  • 00630414972923 ()
L2ZC

  • General specimen container IVD, no additive/medium

IMMULITE® 2000 Systems SBG SHBG - 00630414972916

SHBG - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381198
In Commercial Distribution

  • 00630414972916 ()
L2KSH2

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

IMMULITE® Systems SHBG DIL SHBG - 00630414972831

SHBG Diluent - IMMULITE - CAL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385366
In Commercial Distribution

  • 00630414972831 ()
L1KSHW1

  • Buffered sample diluent IVD

IMMULITE® Systems VB Calibration Verification Material Vitamin B12 - 00630414971421

Vitamin B12 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373710
In Commercial Distribution

  • 00630414971421 ()
LVBCVM

  • Vitamin B12 IVD, control

IMMULITE® TOXOPLASMA QUANT. CVM - 00630414971414

Toxoplasma Quantitative CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373709
In Commercial Distribution

  • 00630414971414 ()
LTXPCVM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems ATA Calibration Verification Material Anti-TPO Ab - 00630414971407

Anti-TPO CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373708
In Commercial Distribution

  • 00630414971407 ()
LTOCVM

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control

IMMULITE® Systems TPI Calibration Verification Material Troponin I - 00630414971391

Troponin I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373707
In Commercial Distribution

  • 00630414971391 ()
LTICVM

  • Troponin I IVD, control
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