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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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AccuDiag ™Herpes Simplex 2 IgG (HSV 2 IgG) ELISA
Diagnostic Automation, Inc.
DACD1403-2
In Commercial Distribution

  • 00850054026088 ()

  • 96 Tests
1403-2

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Lyme Disease Positive Control is intended for use with in vitro assays, for determination of IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. Lyme Disease Positive Control is unassayed without target values and is suitable for use on many analysers.
RANDOX LABORATORIES LIMITED
SR10346
In Commercial Distribution

  • 05055273216394 ()
SR10346

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.
RANDOX LABORATORIES LIMITED
SR10345
In Commercial Distribution

  • 05055273216387 ()
SR10345

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).
ALBA BIOSCIENCE LIMITED
Z443U
In Commercial Distribution

  • 05060242472336 ()
  • 05060242472329 ()
  • 05060242472343 ()
  • 05060242472350 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
Z441U
In Commercial Distribution

  • 05060242471162 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
MultiMix Triple-Colour Control Reagent Mouse IgG1/FITC Rabbit F(ab')2/RPE Rabbit F(ab')2/APC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0979
In Commercial Distribution

  • 05700572020202 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, reagent
Ig Reagent Rabbit F(ab')2/APC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0998
In Commercial Distribution

  • 05700572018735 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, reagent
AccuDiag ™ Herpes Simplex 1 IgG (HSV 1 IgG) ELISA
Diagnostic Automation, Inc.
DACD1401-2
In Commercial Distribution

  • 00850054026095 ()

  • 96 Tests
1401-2

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QMedix™Toxoplasma Gondii IgG ELISA Kit This test is intended for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1101-1
In Commercial Distribution

  • 00850054026002 ()

  • 96 tests
1101-1

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Leishmania species, 6 Well Slide, 8 each pack
MARDX DIAGNOSTICS, INC.
20-04006
In Commercial Distribution

  • 05391516748919 ()
20-04006

  • Multiple Leishmania species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Lyme Negative Control, 250 uL
MARDX DIAGNOSTICS, INC.
32-5001
In Commercial Distribution

  • 05391516748902 ()
32-5001

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
Leismaniasis IFA Test System, 48 Tests
MARDX DIAGNOSTICS, INC.
20-04648
In Commercial Distribution

  • 05391516748698 ()
20-04648

  • Multiple Leishmania species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
MultiMix Dual-Colour Control Reagent Rabbit F(ab')2/FITC Rabbit F(ab')2/RPE
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0935
In Commercial Distribution

  • 05700572516590 ()

  • Total Volume: 0.5 Milliliter


  • Total immunoglobulin G (IgG total) IVD, reagent
Ig Reagent Rabbit F(ab')2/RPE
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0930
In Commercial Distribution

  • 05700572516569 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, reagent
Ig Reagent Rabbit F(ab')2/FITC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0929
In Commercial Distribution

  • 05700572516552 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin G (IgG total) IVD, reagent
MultiMix Triple-Colour Control Reagent Rabbit F(ab')2/FITC Rabbit F(ab')2/RPE Mouse IgG1/RPE-Cy5
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0957
In Commercial Distribution

  • 05700572515395 ()

  • Total Volume: 0.5 Milliliter


  • Total immunoglobulin G (IgG total) IVD, reagent
Captia™ Herpes Simplex Virus 2 (HSV 2) IgG
CLARK LABORATORIES, INC.
2325500
In Commercial Distribution

  • 05391516743495 ()

  • 96 Tests
2325500

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Herpes Simplex Virus 1 (HSV1) ) IgG
CLARK LABORATORIES, INC.
2325400
In Commercial Distribution

  • 05391516743464 ()

  • 96 Tests
2325400

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Toxoplasma gondii IgG
CLARK LABORATORIES, INC.
2325100
In Commercial Distribution

  • 05391516743372 ()

  • 96 Tests
2325100

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ HSV 2 Type Specific IgG
CLARK LABORATORIES, INC.
2323900
In Commercial Distribution

  • 05391516743327 ()

  • 96 Tests
2323900

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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)
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
SM8Z8651G
In Commercial Distribution

  • 00845533001212 ()
SM8Z8651G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
Q8Z8651GB
In Commercial Distribution

  • 00845533001205 ()
Q8Z8651GB

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
8Z8651G
In Commercial Distribution

  • 00845533001199 ()
8Z8651G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Herpes Simplex Virus 2 (HSV 2) IgG
CLARK LABORATORIES, INC.
2325501
In Commercial Distribution

  • 05391516747042 ()

  • 480 Tests
2325501

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Herpes Simplex Virus 1 (HSV1) IgG
CLARK LABORATORIES, INC.
2325401
In Commercial Distribution

  • 05391516747028 ()

  • 480 Tests
2325401

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ Toxoplasma gondii IgG
CLARK LABORATORIES, INC.
2325101
In Commercial Distribution

  • 05391516746960 ()

  • 480 Tests
2325101

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ HSV 2 Type Specific IgG
CLARK LABORATORIES, INC.
2323901
In Commercial Distribution

  • 05391516746939 ()

  • 480 Tests
2323901

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Captia™ HSV 1 Type Specific IgG
CLARK LABORATORIES, INC.
2323801
In Commercial Distribution

  • 05391516746922 ()

  • 480 Tests
2323801

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™Toxoplasma (Toxo) IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the detection and quantitative determination of IgG antibody to Toxoplasma in human sera
Diagnostic Automation, Inc.
DACD1101-1
In Commercial Distribution

  • 00850049545662 ()

  • 96 tests
1101-1

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
AMERICAN NATIONAL RED CROSS
510400/510402
In Commercial Distribution

  • 20858400005095 ()
  • 00858400005091 ()
  • 10858400005098 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
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)
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