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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 MYO Calibration Verification Material Myoglobin - 00630414971292

Myoglobin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373696
In Commercial Distribution

  • 00630414971292 ()
LMYCVM

  • Myoglobin IVD, control

IMMULITE® Systems BP-3 Calibration Verification Material IGBP-3 - 00630414971254

IGFBP-3 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373692
In Commercial Distribution

  • 00630414971254 ()
LGBCVM

  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control

IMMULITE® Systems F4 Calibration Verification Material Free T4 - 00630414971247

Free T4 CVM - IMMULITE -
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373691
In Commercial Distribution

  • 00630414971247 ()
LFT4CVM

  • Free thyroxine (FT4) IVD, control

IMMULITE 2000 Systems Folic Acid Calibration Verification Material - 00630414971230

Folate Acid CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373690
In Commercial Distribution

  • 00630414971230 ()
LFOCVM

  • Folate (vitamin B9) IVD, control

IMMULITE® Systems E2 Calibration Verification Material Estradiol - 00630414971216

Estradiol CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373688
In Commercial Distribution

  • 00630414971216 ()
LE2CVM

  • Estradiol (oestradiol) (E2) IVD, control

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

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

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

ADVIA Centaur® iPTH QC Ref - 00630414587479

PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control

Dimension® CSAE Calibrator - 00842768018213

Cyclosporine Extended Range Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445004
Not in Commercial Distribution

  • 00842768018213 ()
  • 00630414017075 ()
DC108A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
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