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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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Detection of Rubella Virus Antiboby
ARLINGTON SCIENTIFIC, INC.
NC-800096-AG
In Commercial Distribution

  • 00816057020515 ()

  • 96 Test
NC-800096-AG

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Mycobacterium tuberculosis, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB29980 ()
BSB 2998

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, control
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
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
SCIMEDX CORPORATION
I-CTR01G
In Commercial Distribution

  • 00813545025519 ()
I-CTR01G

  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection.
Gold Standard Diagnostics Corporation
720-540
In Commercial Distribution

  • B3507205400 ()
720-540

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection.
Gold Standard Diagnostics Corporation
720-520
In Commercial Distribution

  • B3507205200 ()
720-520

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age.
Gold Standard Diagnostics Corporation
720-360
In Commercial Distribution

  • B3507203600 ()
720-360

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals.
Gold Standard Diagnostics Corporation
720-320
In Commercial Distribution

  • B3507203200 ()
720-320

  • 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)
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)
"720-790 ANA ELISA Screen Test Kit"
DIAMEDIX CORPORATION
720-790
In Commercial Distribution

  • 00817273020396 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, control
"720-540 Mumps IgG Test Kit"
DIAMEDIX CORPORATION
720-540
In Commercial Distribution

  • 00817273020303 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
"720-520 Measles IgG Test Kit"
DIAMEDIX CORPORATION
720-520
In Commercial Distribution

  • 00817273020297 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
"720-400 anti-Cardiolipin IgG/IgM Test Kit"
DIAMEDIX CORPORATION
720-400
In Commercial Distribution

  • 00817273020228 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
"720-380 VZV IgG Test Kit"
DIAMEDIX CORPORATION
720-380
In Commercial Distribution

  • 00817273020211 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
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