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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
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-1003 G
Not in Commercial Distribution

  • 04049016055143 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601 G
In Commercial Distribution

  • 04049016028017 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2610-9601 G
In Commercial Distribution

  • 04049016027973 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Immunoglobulin G Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444983
In Commercial Distribution

  • 00842768005701 ()
  • 00630414004594 ()
DF76

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry
The DRG Cytomegalovirus (CMV) IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CM
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2797
In Commercial Distribution

  • 04048474027976 ()
EIA-2797

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN IRELAND LIMITED
V5191GUS
In Commercial Distribution

  • EBTRV519IGUS02 ()


  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
BioPlex 2200 Lyme Total Calibrator CD
BIO-RAD LABORATORIES, INC.
12000878
In Commercial Distribution

  • 03610520506417 ()

  • 1 Each
12000878

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, calibrator
BioPlex 2200 Lyme Total Calibrator Set
BIO-RAD LABORATORIES, INC.
12000877
In Commercial Distribution

  • 03610520506400 ()

  • 3 Vials
  • Total Volume: 0.5 Milliliter
12000877

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, calibrator
Platelia Aspergillus IgG - negative and positive controls
BIO-RAD
62786
In Commercial Distribution

  • 03610520002490 ()

  • 48 tests
62786

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, control
No Description
ALERE NORTH AMERICA, LLC
84R2
In Commercial Distribution

  • 10859035006245 ()
  • 00859035006248 ()


  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Cytomegalovirus (CMV) IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CM
DRG International Inc
EIA-2797
In Commercial Distribution

  • 00840239027979 ()
EIA-2797

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
4618793160
In Commercial Distribution

  • 04015630939251 ()
4618793160

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
07027770190
In Commercial Distribution

  • 04015630940240 ()
07027770190

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
For the detection and titration of C. trachomatis IgG antibodies in human sera
Hemagen Diagnostics, Inc.
903001
In Commercial Distribution

  • G5229030011 ()


  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of C. trachomatis IgG antibodies in human sera.
Hemagen Diagnostics, Inc.
903000
In Commercial Distribution

  • G5229030001 ()


  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902801
In Commercial Distribution

  • G5229028011 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
902800
In Commercial Distribution

  • G5229028001 ()


  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-CTR01G
In Commercial Distribution

  • 00813545025519 ()
I-CTR01G

  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection.
Gold Standard Diagnostics Corporation
720-540
In Commercial Distribution

  • B3507205400 ()
720-540

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection.
Gold Standard Diagnostics Corporation
720-520
In Commercial Distribution

  • B3507205200 ()
720-520

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age.
Gold Standard Diagnostics Corporation
720-360
In Commercial Distribution

  • B3507203600 ()
720-360

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals.
Gold Standard Diagnostics Corporation
720-320
In Commercial Distribution

  • B3507203200 ()
720-320

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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)
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)
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)
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 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 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 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 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
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
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
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
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
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
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
Toxoplasma IgG Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
803re
In Commercial Distribution

  • 00850011135549 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
aHBs Calibration Verification / Linearity Test kit
Lgc Clinical Diagnostics, Inc.
801mm
In Commercial Distribution

  • 00850011135495 ()


  • Hepatitis B virus surface immunoglobulin G (IgG) antibody IVD, control
VZV IgG EIA
Bio-RAD Laboratories, Inc.
25180
In Commercial Distribution

  • 00847865010757 ()

  • 96 Tests
25180

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