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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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An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum.
KRONUS, INC.
KR7730
In Commercial Distribution

  • B126KR77300 ()
KR7730

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
KRONUS, INC.
KR7110
In Commercial Distribution

  • B126KR71100 ()
KR7110

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
An enzyme linked immunosorbent assay for the qualitative determination of autoantibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR7015
In Commercial Distribution

  • B126KR70150 ()
KR7015

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300G-5
In Commercial Distribution

  • 20816101022018 ()
EL0300G-5

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0300G
In Commercial Distribution

  • 20816101022001 ()
EL0300G

  • West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
T. pallidum WB IgG Positive Control, 250µl
MARDX DIAGNOSTICS, INC.
40-5023
In Commercial Distribution

  • 05391516749138 ()
40-5023

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control
T. pallidum WB Negative Control, 250µl
MARDX DIAGNOSTICS, INC.
40-5021
In Commercial Distribution

  • 05391516749121 ()
40-5021

  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control
Uni-Gold™ Giardia, 20 Tests
MARDX DIAGNOSTICS, INC.
1206610
In Commercial Distribution

  • 05391516746328 ()
1206610

  • Giardia lamblia immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
PK7400 TP HA CONTROLS is intended for use with the PK7400 TP HA REAGENT (B11186) for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies in human serum, EDTA plasma and CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System.
NEWMARKET BIOMEDICAL LIMITED
B11187
In Commercial Distribution

  • 05060515140047 ()

  • 16 x 5mL


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control
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