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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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Diamedix - 00817273020174

"720-340 HSV 1&2 IgG Test Kit"
DIAMEDIX CORPORATION
720-340
In Commercial Distribution

  • 00817273020174 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)

Diamedix - 00817273020150

"720-320 CMV IgG Test Kit"
DIAMEDIX CORPORATION
720-320
In Commercial Distribution

  • 00817273020150 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)

Access Rubella IgG - 15099590624897

The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
34430
In Commercial Distribution

  • 15099590624897 ()
34430

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Access Rubella IgG Calibrators - 15099590624880

The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella IgG assay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
33435
In Commercial Distribution

  • 15099590624880 ()
34435

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Access Rubella IgG QC - 15099590624873

The Access Rubella IgG QC is intended for monitoring the system performance of the Access Rubella IgG assay.
Beckman Coulter, Inc.
34439
In Commercial Distribution

  • 15099590624873 ()
34439

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Mumps Virus IgG - ENTIMUMG03400

The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
MUMG0340
In Commercial Distribution

  • ENTIMUMG03400 ()
MUMG0340

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Measles Virus IgG - ENTIMEAG03300

The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
MEAG0330
In Commercial Distribution

  • ENTIMEAG03300 ()
MEAG0330

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Liquichek - 00847661000532

Liquichek ToRCH Plus Control, Negative MiniPak (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
228X
In Commercial Distribution

  • 00847661000532 ()
228X

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Treponema pallidum reagin antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control

Liquichek - 00847661000495

Liquichek ToRCH Plus Control, Positive MiniPak (An unassayed (human) Serology control.)
BIO-RAD LABORATORIES, INC.
239X
In Commercial Distribution

  • 00847661000495 ()
239X

  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Treponema pallidum reagin antibody IVD, control

Liquichek - 00847661000259

Liquichek ToRCH Plus Control, Negative (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
228
In Commercial Distribution

  • 00847661000259 ()
228

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
  • Treponema pallidum reagin antibody IVD, control
  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control

Liquichek - 00847661000235

Liquichek ToRCH Plus Control, Positive (An unassayed (human) Serology control.)
BIO-RAD LABORATORIES, INC.
239
In Commercial Distribution

  • 00847661000235 ()
239

  • Treponema pallidum reagin antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
  • Multiple infectious organism/newborn TORCH screen IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control

AtheNA Multi-Lyte® EBV IgG Plus Test System - 00845533000031

The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus (EBV) IgG Plus Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, total EBV-EA, and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used as an aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the disease caused by Epstein-Barr Virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A92101G
In Commercial Distribution

  • 00845533000031 ()
A92101G

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865012614

Manual & CDs, EBV IgG IFU, SW4.1v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012614 ()

  • 1 Each
6651260F

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865012607

EBV IgG Assay Protocol File CD, SW4.1_v1, US
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012607 ()

  • 1 Each
6651270D

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002226

EBV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002226 ()

  • 1 Each
6651270C

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002127

Manual & CDs, BioPlex 2200, EBV IgG IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002127 ()

  • 1 Each
6651260E

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865000161

EBV IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6651250
In Commercial Distribution

  • 00847865000161 ()

  • 100 Tests
6651250

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

SeraQuest - 00850487007531

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
H.pylori G
In Commercial Distribution

  • 00850487007531 ()
01550Q-1

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SeraQuest - 00850487007340

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
VZV G
In Commercial Distribution

  • 00850487007340 ()
Q01-180

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ReQuest - 00850487007159

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
H.pylori G
In Commercial Distribution

  • 00850487007159 ()
01550Q-1

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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