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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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Syphilis IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6631400
In Commercial Distribution

  • 00847865000253 ()

  • Total Volume: 0.5 Milliliter
  • 4 Vials
6631400

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, calibrator
Toxoplasma IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469600
In Commercial Distribution

  • 00630414976747 ()
LTXPCM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Human-antisera, Pseudomonas-CF-IgG
Ssi Diagnostica A/S
64742
Not in Commercial Distribution

  • 05713106647424 ()
64742

  • Pseudomonas aeruginosa immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2808
In Commercial Distribution

  • 04048474028089 ()
EIA-2808

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum.
BIOMERIEUX SA
30217
In Commercial Distribution

  • 03573026064518 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Varicella-Zoster Virus (VZV) IgG Enzyme-linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Diagnostic Automation, Inc.
DACD1412-1
In Commercial Distribution

  • 00894175000015 ()

  • 96 tests
1412-1

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection.
Gold Standard Diagnostics Corporation
720-380
In Commercial Distribution

  • B3507203800 ()
720-380

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0082
In Commercial Distribution

  • 00816784020390 ()
2015-0082

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Detection of Varicella Zoster Antibody
ARLINGTON SCIENTIFIC, INC.
NC-840096-AG
In Commercial Distribution

  • 00816057020584 ()

  • 96 Test
NC-840096-AG

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum.
KRONUS, INC.
KR8200
In Commercial Distribution

  • B126KR82000 ()
KR8200

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
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