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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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A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
T045
Not in Commercial Distribution

  • 00816879022056 ()
749740

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
T042
Not in Commercial Distribution

  • 00816879022049 ()
749720

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9420
In Commercial Distribution

  • M52594200 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9410
In Commercial Distribution

  • M52594100 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9250
In Commercial Distribution

  • M52592500 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
The RIDA® CCD-Inhibitor is an accessory for use in in vitro diagnostics for the inhibition of anti-CCD IgE in human serum and plasma.
R-Biopharm AG
ZA0601
In Commercial Distribution

  • 04049095260049 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HYCOR BIOMEDICAL LLC
G001
In Commercial Distribution

  • 00816879023916 ()
8632780

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Support Patient arm
ADEPT MEDICAL LIMITED
E
In Commercial Distribution

  • 09421905187565 ()
AM100E

  • Radiological arm/leg positioner
The Macy Catheter is intended to provide rectal access to administer liquids/medications.
HOSPI CORPORATION
E
In Commercial Distribution

  • 00861003000202 ()
MAC-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "E" is labeled for connections to electrodes 257-320.
NEURALYNX, INC.
-E
In Commercial Distribution

  • 00850011306413 ()
31-0602-0037

  • Electrical-only medical device connection cable, reusable
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