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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
T202
Not in Commercial Distribution

  • 00816879021707 ()
74426

  • 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
M006
Not in Commercial Distribution

  • 00816879021585 ()
74388

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
96 well ELISA for the detection of Anti-Tissue Transglutaminase IgG antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA26
Not in Commercial Distribution

  • 00816879020267 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
96 well ELISA for the detection of Anti-Tissue Transglutaminase IgA antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA25
Not in Commercial Distribution

  • 00816879020250 ()


  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
96 well ELISA for the detection of anti-cardiolipin antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA18
Not in Commercial Distribution

  • 00816879020182 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
96 well ELISA for the detection of anti-Cardiolipin IgM antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA16
Not in Commercial Distribution

  • 00816879020168 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
96 well ELISA for the detection of Anti-Cardiolipin IgG antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA15
Not in Commercial Distribution

  • 00816879020151 ()


  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
10675-300
In Commercial Distribution

  • 00816870024844 ()

  • Width: 7.75 Inch
10675-300B

  • Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
10625-300
In Commercial Distribution

  • 00816870024806 ()

  • Width: 7.75 Inch
10625-300B

  • Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
10175-300
In Commercial Distribution

  • 00816870024776 ()

  • Width: 7.75 Inch
10175-300B

  • Aldosterone IVD, kit, enzyme immunoassay (EIA)
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