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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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No Description
DIASORIN MOLECULAR LLC
IB0910
In Commercial Distribution

  • 10816101021038 ()
IB0910

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
DIASORIN MOLECULAR LLC
IB0913
In Commercial Distribution

  • 10816101021021 ()
IB0913

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
DIASORIN MOLECULAR LLC
IB0900G
In Commercial Distribution

  • 20816101021004 ()
IB0900G

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
Kit HSV 1/Hsv2 Qx Amplified Dna Assay
BECTON, DICKINSON AND COMPANY
441749
Not in Commercial Distribution

  • 00382904417499 ()
441749

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
The ZEUS AtheNA Multi-Lyte® Herpes Simplex Virus (HSV)-1 & 2 IgG Plus Test System is intended for the qualitative detection of presence or absence of IgG antibodies to HSV-1 and HSV-2 in human serum. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A97101G
In Commercial Distribution

  • 00845533000055 ()
A97101G

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
HSV-1 & HSV-2 Reagent Pack
BIO-RAD LABORATORIES, INC.
6653350
In Commercial Distribution

  • 00847865000949 ()

  • 100 Tests
6653350

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865010993 ()

  • 1 Each
6653370E

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865004725 ()

  • 1 Each
6653360E

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
HSV-1 & HSV-2 Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002479 ()

  • 1 Each
6653370D

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865002172 ()

  • 1 Each
6653360F

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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