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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 - 30014613336013

INTL-ONLY ELVIS STAIN KT 100TE
DIAGNOSTIC HYBRIDS, INC.
I-SK-ELVIS-100
In Commercial Distribution

  • 30014613336013 ()
I-SK-ELVIS-100

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

D3 - 30014613330707

D3 DFA HSV ID AND TYPING KIT
DIAGNOSTIC HYBRIDS, INC.
DFA HSV ID and Typing ID Kit
In Commercial Distribution

  • 30014613330707 ()
01-090000

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

D3 - 30014613330684

D3 DFA HERPES SIMPLEX ID KIT
DIAGNOSTIC HYBRIDS, INC.
DFA HSV ID Kit
In Commercial Distribution

  • 30014613330684 ()
01-080000

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

ELVIS - 30014613330202

ELVIS SOL 3, 12ML
DIAGNOSTIC HYBRIDS, INC.
00-013012.V2
In Commercial Distribution

  • 30014613330202 ()
00-013012.V2

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

ELVIS - 30014613330196

ELVIS SOL 3, 3ML
DIAGNOSTIC HYBRIDS, INC.
00-013003.V2
In Commercial Distribution

  • 30014613330196 ()
00-013003.V2

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

ELVIS - 30014613330165

ELVIS SOL 1, 85ML
DIAGNOSTIC HYBRIDS, INC.
00-011085
In Commercial Distribution

  • 30014613330165 ()
00-011085

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

ELVIS - 30014613330158

ELVIS SOL 1, 15ML
DIAGNOSTIC HYBRIDS, INC.
00-011015
In Commercial Distribution

  • 30014613330158 ()
00-011015

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

ELVIS - 30014613330127

ELVIS SOL 1, 130ML
DIAGNOSTIC HYBRIDS, INC.
00-001130
In Commercial Distribution

  • 30014613330127 ()
00-001130

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

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
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