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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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BioSign® Rubella card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-171-35-01
In Commercial Distribution

  • 10743816001027 ()
BSP-171-35-01

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8005-96
In Commercial Distribution

  • 00811727015198 ()
T8005-96

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8003-96
In Commercial Distribution

  • 00811727015174 ()
T8003-96

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
RSN-9010
In Commercial Distribution

  • B110RSN90100 ()
RSN-9010

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
RSG-9020
In Commercial Distribution

  • B110RSG90200 ()
RSG-9020

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control
No Description
MONOBIND, INC.
6525-300
In Commercial Distribution

  • 00816870024257 ()

  • Width: 7.75 Inch
6525-300B

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6525-300
In Commercial Distribution

  • 00816870024240 ()

  • Width: 7.75 Inch
6525-300A

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6325-300
In Commercial Distribution

  • 00816870024172 ()

  • Width: 7.75 Inch
6325-300B

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
6325-300
In Commercial Distribution

  • 00816870024165 ()

  • Width: 7.75 Inch
6325-300A

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-790 ANA ELISA Screen Test Kit"
DIAMEDIX CORPORATION
720-790
In Commercial Distribution

  • 00817273020396 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, control
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