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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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Adenovirus Antigen Substrate, 12 wells, For IFA Test System - B110AD31120

No Description
Bion Enterprises, Ltd.
AD-3112
In Commercial Distribution

  • B110AD31120 ()
AD-3112

  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent

Toxoplasma gondii control slides - B502BSB60490

Toxoplasma gondii , control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB60490 ()
BSB 6049

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control

Diamedix - 00817273020419

"720-850 Mycoplasma IgG Test Kit"
DIAMEDIX CORPORATION
720-850
In Commercial Distribution

  • 00817273020419 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control

Diamedix - 00817273020402

"720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit"
DIAMEDIX CORPORATION
720-830
In Commercial Distribution

  • 00817273020402 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control

Toxoplasma gondii Control Slides - B502BSB9416CS0

Toxoplasma gondii Control Slides
BIO SB, INC.
BSB-9416-CS
In Commercial Distribution

  • B502BSB9416CS0 ()
BSB-9416-CS

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, control

Schistosoma Antibody 96 Tests - 00813545026455

No Description
SCIMEDX CORPORATION
SCHISTO-96
In Commercial Distribution

  • 00813545026455 ()
SCHISTO-96

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Leptospira IgG Antibody 96 Test - 00813545026318

No Description
SCIMEDX CORPORATION
LEPTO-G
In Commercial Distribution

  • 00813545026318 ()
LEPTO-G

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

IMMY - 00816387021152

No Description
Immuno-Mycologics, Inc.
CTA2003
In Commercial Distribution

  • 00816387021152 ()
  • 00816387021169 ()


  • Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Parainfluenza Virus 1, 2, 3 IgG - ENTIPAIG03600

The Parainfluenza Virus 1, 2, 3 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Parainfluenza Virus 1, 2, 3 in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
PAIG0360
In Commercial Distribution

  • ENTIPAIG03600 ()
PAIG0360

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Leptospira IgG - ENTILEPG06600

The Leptospira IgG ELISA is intended for the qualitative determination of IgG class antibodies against Leptospira spp. in human serum or plasma (heparin).
Gold Standard Diagnostics Frankfurt GmbH
LEPG0660
In Commercial Distribution

  • ENTILEPG06600 ()
LEPG0660

  • Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Brucella IgG - ENTIBRUG00500

The Brucella IgG ELISA is intended for the qualitative determination of IgG class antibodies against Brucella in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
BRUG0050
In Commercial Distribution

  • ENTIBRUG00500 ()
BRUG0050

  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

EBV Negative Control - B110EBN50100

No Description
Bion Enterprises, Ltd.
EBN-5010
In Commercial Distribution

  • B110EBN50100 ()
EBN-5010

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control

Trident - 04546540516879

Alpha Code H
Howmedica Osteonics Corp.
625-0T-36H
In Commercial Distribution

  • 04546540516879 ()

  • Degree: 0.0 Degree
  • Lumen/Inner Diameter: 36.0 Millimeter
625-0T-36H

  • Ceramic acetabular liner

Trident - 04546540516862

Alpha Code G
Howmedica Osteonics Corp.
625-0T-36G
In Commercial Distribution

  • 04546540516862 ()

  • Lumen/Inner Diameter: 36.0 Millimeter
  • Degree: 0.0 Degree
625-0T-36G

  • Ceramic acetabular liner

Trident - 04546540516855

Alpha Code F
Howmedica Osteonics Corp.
625-0T-32F
In Commercial Distribution

  • 04546540516855 ()

  • Lumen/Inner Diameter: 32.0 Millimeter
  • Degree: 0.0 Degree
625-0T-32F

  • Ceramic acetabular liner

Trident - 04546540516848

Alpha Code E
Howmedica Osteonics Corp.
625-0T-32E
In Commercial Distribution

  • 04546540516848 ()

  • Lumen/Inner Diameter: 32.0 Millimeter
  • Degree: 0.0 Degree
625-0T-32E

  • Ceramic acetabular liner

Trident - 04546540516831

Alpha Code D
Howmedica Osteonics Corp.
625-0T-28D
In Commercial Distribution

  • 04546540516831 ()

  • Degree: 0.0 Degree
  • Lumen/Inner Diameter: 28.0 Millimeter
625-0T-28D

  • Ceramic acetabular liner

Trident - 04546540259936

Alpha Code I
Howmedica Osteonics Corp.
625-0T-36I
In Commercial Distribution

  • 04546540259936 ()

  • Degree: 0.0 Degree
  • Lumen/Inner Diameter: 36.0 Millimeter
625-0T-36I

  • Ceramic acetabular liner

Validate - 00850011135402

Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control
Lgc Clinical Diagnostics, Inc.
510mm
In Commercial Distribution

  • 00850011135402 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Isotype Reagent Mo IgG1/APC - 05700572516682

Isotype Reagent Mouse IgG1/APC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0968
In Commercial Distribution

  • 05700572516682 ()

  • Total Volume: 1 Milliliter


  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
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