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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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Captia™ HSV 1 Type Specific IgG
CLARK LABORATORIES, INC.
2323800
In Commercial Distribution

  • 05391516743310 ()

  • 96 Tests
2323800

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 2 G
In Commercial Distribution

  • 00850487007555 ()
Q01-420

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 1 G
In Commercial Distribution

  • 00850487007548 ()
01-410

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
TOXO G
In Commercial Distribution

  • 00850487007401 ()
Q01-120

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 1 G
In Commercial Distribution

  • 00850487007135 ()
01-410

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
HSV Type 2 G
In Commercial Distribution

  • 00850487007128 ()
Q01-420

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
TOXO G
In Commercial Distribution

  • 00850487007036 ()
Q01-120

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9751G
In Commercial Distribution

  • 00845533000758 ()
SM9Z9751G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9751G
In Commercial Distribution

  • 00845533000741 ()
9Z9751G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Herpes Simplex Virus-1 (HSV-1) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9701G
In Commercial Distribution

  • 00845533000734 ()
SM9Z9701G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Herpes Simplex Virus-1 (HSV-1) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9701G
In Commercial Distribution

  • 00845533000727 ()
9Z9701G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
SM9Z9781G
In Commercial Distribution

  • 00845533000697 ()
SM9Z9781G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The assay is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
9Z9781G
In Commercial Distribution

  • 00845533000680 ()
9Z9781G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
SM9Z9761G
In Commercial Distribution

  • 00845533000673 ()
SM9Z9761G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA HSV gG-1 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-1 infection. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1. The test is not intended for donor screening or for self testing. The performance of this test has not been established for use in a pediatric population, neonates, children, or immuno-compromised patients.
ZEUS SCIENTIFIC, INC.
9Z9761G
In Commercial Distribution

  • 00845533000666 ()
9Z9761G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN SPA
310542
Not in Commercial Distribution

  • 08056771601795 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN SPA
310542
In Commercial Distribution

  • 08056771102995 ()


  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma.
BIOMERIEUX SA
30210-01
In Commercial Distribution

  • 03573026156855 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag™ Ascaris IgG ELISA For the qualitative detection of immunoglobulin G (IgG) antibodies to the parasitic nematode Ascaris lumbricoides in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD8212-35
In Commercial Distribution

  • 00894175000831 ()

  • 96 Tests
8212-35

  • Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 10 Strip
In Commercial Distribution

  • 18055182872876 ()
  • 08055182872879 ()
  • 08055182872855 ()
$92103-10

  • Penicillin G minimum inhibitory concentration (MIC) IVD
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 1 Strip
In Commercial Distribution

  • 28055182872866 ()
  • 08055182872862 ()
  • 18055182872869 ()
$92103-1

  • Penicillin G minimum inhibitory concentration (MIC) IVD
No Description
Bion Enterprises, Ltd.
PN-8510
Not in Commercial Distribution

  • B110PN85100 ()
PN-8510

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
PG-8520
Not in Commercial Distribution

  • B110PG85200 ()
PG-8520

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CHG-4120
In Commercial Distribution

  • B110CHG41200 ()
CHG-4120

  • Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
BBN-6110
In Commercial Distribution

  • B110BBN61100 ()
BBN-6110

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8001-96
In Commercial Distribution

  • 00811727015150 ()
T81001-96

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-370 Rubella IgM Test Kit"
DIAMEDIX CORPORATION
720-370
In Commercial Distribution

  • 00817273020204 ()


  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
"720-360 Rubella IgG Test Kit"
DIAMEDIX CORPORATION
720-360
In Commercial Distribution

  • 00817273020198 ()


  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
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