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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 3gAllergy Specific IgE Positive Control For D1 - 00630414984568

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

NOVEOS IgE Positive Control Pack - 00816879029543

No Description
HYCOR BIOMEDICAL LLC
63150Z
In Commercial Distribution

  • 00816879029543 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Negative Control Pack - 00816879029536

No Description
HYCOR BIOMEDICAL LLC
63155Z
In Commercial Distribution

  • 00816879029536 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Negative Control Pack - 00816879023039

No Description
HYCOR BIOMEDICAL LLC
63155
In Commercial Distribution

  • 00816879023039 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Positive Control Pack - 00816879023022

No Description
HYCOR BIOMEDICAL LLC
63150
In Commercial Distribution

  • 00816879023022 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

SPECIFIC IGE CONTROL KIT - 00816879022063

No Description
HYCOR BIOMEDICAL LLC
71207
Not in Commercial Distribution

  • 00816879022063 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

ImmunoCard STAT! EHEC - 00840733101366

ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.
MERIDIAN BIOSCIENCE, INC.
751630
In Commercial Distribution

  • 00840733101366 ()
751630

  • Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA)

CARDINAL HEALTH - 10888439200058

E P PACK
Cardinal Health 200, LLC
SAN35EPSTI
In Commercial Distribution

  • 50888439200056 ()
  • 10888439200058 ()
SAN35EPSTI

  • Angiography kit

ARCHITECT - 00380740054243

Quantia Immunoglobulin E
ABBOTT LABORATORIES
6K42-40
In Commercial Distribution

  • 00380740054243 ()
06K4240

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, nephelometry/turbidimetry

Medline Industries, Inc. - 10888277073319

E P PACK
MEDLINE INDUSTRIES, INC.
DYNJ43898
In Commercial Distribution

  • 10888277073319 ()
DYNJ43898

  • General surgical procedure kit, non-medicated, reusable
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