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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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ELVIS - 30014613330110

ELVIS SOL 1, 26ML
DIAGNOSTIC HYBRIDS, INC.
00-001026
In Commercial Distribution

  • 30014613330110 ()
00-001026

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Herpes Simplex Negative Control - B110HSN35100

No Description
Bion Enterprises, Ltd.
HSN-3510
In Commercial Distribution

  • B110HSN35100 ()
HSN-3510

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

BioPlex 2200 - 00847865000932

HSV-1 & HSV-2 Control Lot Data
BIO-RAD LABORATORIES, INC.
6633340
In Commercial Distribution

  • 00847865000932 ()

  • 1 Each
6633340

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

BioPlex 2200 - 00847865000925

HSV-1 & HSV-2 IgG Control Set
BIO-RAD LABORATORIES, INC.
6633330
In Commercial Distribution

  • 00847865000925 ()

  • 4 Vials
  • Total Volume: 1.5 Milliliter
6633330

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

BioPlex 2200 - 00847865000918

HSV-1 & HSV-2 IgG Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6633320
In Commercial Distribution

  • 00847865000918 ()

  • 1 Each
6633320

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

BioPlex 2200 - 00847865000901

HSV-1 & HSV-2 IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6633300
In Commercial Distribution

  • 00847865000901 ()

  • 4 Vials
  • Total Volume: 0.5 Milliliter
6633300

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

NA - 05700573075706

No Description
OXOID LIMITED
K610611-2
In Commercial Distribution

  • 05700573075706 ()


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

Herpes Simplex IgM Control - B110HSM35300

No Description
Bion Enterprises, Ltd.
HSM-3530
In Commercial Distribution

  • B110HSM35300 ()
HSM-3530

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control

Herpes Simplex IgG Control - B110HSG35200

No Description
Bion Enterprises, Ltd.
HSG-3520
In Commercial Distribution

  • B110HSG35200 ()
HSG-3520

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

HSV Serum Panel - 10816101022202

No Description
DIASORIN MOLECULAR LLC
EL0950
In Commercial Distribution

  • 10816101022202 ()
EL0950

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