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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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Measles IgG Test System, 120 Tests - B110MEG1200

No Description
Bion Enterprises, Ltd.
MEG-120
In Commercial Distribution

  • B110MEG1200 ()
MEG-120

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

NovaLisa Adenovirus IgG - ENTIADVG00100

The Adenovirus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Adenovirus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ADVG0010
In Commercial Distribution

  • ENTIADVG00100 ()
ADVG0010

  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Tinto Cathepsin K (BSB-172) - B502BSB3800150

Tinto Cathepsin K 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.
BSB-3800-15
In Commercial Distribution

  • B502BSB3800150 ()

  • Total Volume: 15 Milliliter
BSB-3800-15

  • Cathepsin IVD, antibody

Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit - G5229030011

For the detection and titration of C. trachomatis IgG antibodies in human sera
Hemagen Diagnostics, Inc.
903001
In Commercial Distribution

  • G5229030011 ()


  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Chlamydia trachomatis / C. trach IgG IFA 96 Test - G5229030001

For the detection and titration of C. trachomatis IgG antibodies in human sera.
Hemagen Diagnostics, Inc.
903000
In Commercial Distribution

  • G5229030001 ()


  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit - G5229028011

For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902801
In Commercial Distribution

  • G5229028011 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Varicella-Zoster Virus / VZV IgG IFA 96 Test - G5229028001

For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902800
In Commercial Distribution

  • G5229028001 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Biotrin Parvovirus B19 IgG EIA - EBTRV519IGUS02

No Description
DIASORIN IRELAND LIMITED
V5191GUS
In Commercial Distribution

  • EBTRV519IGUS02 ()


  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Biotrin Parvovirus B19 IgG EIA - 08056771103343

No Description
DIASORIN SPA
V519IGUS
In Commercial Distribution



  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit - B3507205400

ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection.
Gold Standard Diagnostics Corporation
720-540
In Commercial Distribution

  • B3507205400 ()
720-540

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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