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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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HerpeSelect® 1 and 2 Immunoblot IgG - 20816101021004

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

HSV ELISA Negative Control - 10816101022080

No Description
DIASORIN MOLECULAR LLC
EL0904
In Commercial Distribution

  • 10816101022080 ()
EL0904

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

HSV-1 and HSV-2 Immunoblot IgG Negative Control - 10816101021038

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

HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control - 10816101021021

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

Simplexa™ HSV 1 & 2 Direct - 20816101025507

No Description
DIASORIN MOLECULAR LLC
MOL2150
In Commercial Distribution

  • 20816101025507 ()
MOL2150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Elecsys HSV-2 IgG - 07613336170694

No Description
Roche Diagnostics GmbH
08948887160
In Commercial Distribution

  • 07613336170694 ()
08948887160

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

Elecsys HSV-2 IgG - 07613336170687

No Description
Roche Diagnostics GmbH
08948909190
In Commercial Distribution

  • 07613336170687 ()
08948909190

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

Elecsys HSV-1 IgG - 07613336170663

No Description
Roche Diagnostics GmbH
08948844160
In Commercial Distribution

  • 07613336170663 ()
08948844160

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

Elecsys HSV-1 IgG - 07613336170656

No Description
Roche Diagnostics GmbH
08948852190
In Commercial Distribution

  • 07613336170656 ()
08948852190

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

Alethia™ HSV 1&2 - 00840733102219

The Alethia™ HSV 1&2 DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. Alethia™ HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from Alethia™ HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.
MERIDIAN BIOSCIENCE, INC.
480650
In Commercial Distribution

  • 00840733102219 ()
480650

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

illumigene HSV 1&2 - 00840733101182

The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.
MERIDIAN BIOSCIENCE, INC.
280650
Not in Commercial Distribution

  • 00840733101182 ()
280650

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Elecsys HSV-1 IgG - 04015630940431

No Description
Roche Diagnostics GmbH
07027494190
In Commercial Distribution

  • 04015630940431 ()
07027494190

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

Elecsys HSV-2 IgG - 04015630940448

No Description
Roche Diagnostics GmbH
07027508190
In Commercial Distribution

  • 04015630940448 ()
07027508190

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

Elecsys HSV2 IgG Immunoassay - 04015630939053

No Description
Roche Diagnostics GmbH
5572193160
In Commercial Distribution

  • 04015630939053 ()
5572193160

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

Elecsys HSV1 IgG Immunoassay - 04015630939046

No Description
Roche Diagnostics GmbH
5572185160
In Commercial Distribution

  • 04015630939046 ()
5572185160

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

Mutlicode®-RTx HSV 1&2 Kit - 00840487101032

The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.
LUMINEX CORPORATION
3711
Not in Commercial Distribution

  • 00840487101032 ()
3711

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

ARIES® HSV 1&2 Assay - 00840487100295

The ARIES® HSV 1 & 2 Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus (HSV) DNA from cutaneous and mucocutaneous lesion swab specimens.
LUMINEX CORPORATION
50-10017
In Commercial Distribution

  • 00840487100295 ()


  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG - 00630414964171

HSV I and II IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381274
In Commercial Distribution

  • 00630414964171 ()
LKHS1

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

IMMULITE® 2000 Systems Herpes I and II IgG - 00630414999784

IMMULITE® 2000 Systems Herpes I and II IgG
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381333
In Commercial Distribution

  • 00630414999784 ()
L2KHVG6

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

BioPlex 2200 - 00847865010993

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
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