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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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The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only. The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution

  • 15099590738655 ()
C58963

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6530
In Commercial Distribution

  • 05060169695979 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
Captia™ Chlamydia IgG
CLARK LABORATORIES, INC.
2346200
In Commercial Distribution

  • 05391516743952 ()

  • 96 Tests
2346200

  • Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P3-9112
Not in Commercial Distribution

  • B110P391120 ()
P3-9112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P2-8112
Not in Commercial Distribution

  • B110P281120 ()
P2-8112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
P1-7112
Not in Commercial Distribution

  • B110P171120 ()
P1-7112

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
CB-3312
In Commercial Distribution

  • B110CB33120 ()
CB-3312

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
CB-3306
In Commercial Distribution

  • B110CB33060 ()
CB-3306

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
No Description
AALTO SCIENTIFIC
K087M-6
In Commercial Distribution

  • B085K087M60 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
AALTO SCIENTIFIC
K077M-6
In Commercial Distribution

  • B085K077M60 ()


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