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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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IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB56620 ()
BSB 5662

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB56610 ()
BSB 5661

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56600 ()
BSB 5660

  • Total immunoglobulin A (IgA total) IVD, antibody
Tinto IgA is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56590 ()
BSB 5659

  • Total immunoglobulin A (IgA total) IVD, antibody
VITROS Immunodiagnostic Products Anti-HAV Total Controls
ORTHO CLINICAL DIAGNOSTICS
6801463
In Commercial Distribution

  • 10758750001293 ()
6801463

  • Hepatitis A virus total antibody IVD, control
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3913
Not in Commercial Distribution

  • 00840487101360 ()
3913

  • Influenza A virus nucleic acid IVD, reagent
Control swabs intended for use only with Strep A product.
Alere Scarborough, Inc.
730-010
In Commercial Distribution

  • 10811877010446 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, control
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control
The Follistatin enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of follistatin in human serum and other biological fluids. This kit is intended for in-vitro diagnostic use.
Ansh Labs, LLC
AL-117-i
In Commercial Distribution

  • 00853592008387 ()
AL-117-i

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Inhibin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum. It is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
Ansh Labs, LLC
AL-123
In Commercial Distribution

  • 00853592008097 ()
AL-123

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
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