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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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Tinto IgA MMab - B502BSB56610

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 MMab - B502BSB56600

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 MMab - B502BSB56590

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

IgA Control Slides - B502BSB9233CS0

IgA Control Slides
BIO SB, INC.
BSB-9233-CS
In Commercial Distribution

  • B502BSB9233CS0 ()
BSB-9233-CS

  • Immunoglobulin A subclass (IgA subclass) IVD, control

QuickVue - 30014613003540

Strep A Liquid Ctrl
QUIDEL CORPORATION
00354
In Commercial Distribution

  • 30014613003540 ()
00354

  • Beta-haemolytic Group A Streptococcus antigen IVD, control

QuickVue In-Line - 30014613003458

QkVue InLine Strep A Ctrl Set
QUIDEL CORPORATION
00345
In Commercial Distribution

  • 30014613003458 ()
00345

  • Beta-haemolytic Group A Streptococcus antigen IVD, control

Access Inhibin A Calibrators - 15099590203054

The Access Inhibin A Calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric inhibin A levels in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems.
Beckman Coulter, Inc.
A36098
In Commercial Distribution

  • 15099590203054 ()
A36098

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

Inhibin A ELISA - 15099590180430

Inhibin A ELISA 1 Plate (96 Tests)
Beckman Coulter, Inc.
DSL-10-28100-1
In Commercial Distribution

  • 15099590180430 ()
DSL-10-28100-1

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

Access Inhibin A QC - 15099590203061

The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.
Beckman Coulter, Inc.
A36100
In Commercial Distribution

  • 15099590203061 ()
A36100

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

Access Inhibin A - 15099590203047

The Access Inhibin A assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of dimeric inhibin A in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems.
Beckman Coulter, Inc.
A36097
In Commercial Distribution

  • 15099590203047 ()
A36097

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