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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Specific IgE D2 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485105
In Commercial Distribution

  • 00630414984575 ()
DC2LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Specific IgE D1 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485104
In Commercial Distribution

  • 00630414984568 ()
DC1LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
MTS DR. SCHWARTZ KIT-MED CTR CTL GA
MEDLINE INDUSTRIES, INC.
60130797
In Commercial Distribution

  • 20193489046547 ()
  • 10193489046540 ()
60130797

  • Angiography kit
HAV total QC kit - CENTAUR - CTL - 2x2x7mL
Siemens Healthcare Diagnostics Inc.
10309005
In Commercial Distribution

  • 00630414509259 ()
1313752

  • Hepatitis A virus total antibody IVD, control
Active B12 Control Set - CENTAUR - CTL - 1x2x7mL
Siemens Healthcare Diagnostics Inc.
10995091
In Commercial Distribution

  • 00630414603124 ()
10995091

  • Holotranscobalamin (holoTC) IVD, control
aCCP Control Set - CENTAUR - - CENTAUR - CTL - 1x2x7mL
Siemens Healthcare Diagnostics Inc.
10699150
In Commercial Distribution

  • 00630414592329 ()
10699150

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control
Serum Tox Kit - ADVIA Chem. - CTL - 6x5mL
Siemens Healthcare Diagnostics Inc.
10286267
Not in Commercial Distribution

  • 00630414553733 ()
4663525

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Liquid Diptube Urine ControlsLiquid Diptube Urine Ctl Set
BTNX Inc
AUCT-1V1
In Commercial Distribution

  • 00722066001912 ()


  • Multiple urine analyte IVD, control
CERAMAGE UP TG 5G
SHOFU DENTAL CORPORATION
2364
In Commercial Distribution

  • E23523640 ()
2364

  • Dental prosthesis veneer resin
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