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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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Anti-Measles Virus ELISA (IgG) - 04049016027973

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)

Alere Rubella-plus® - 10859035006245

No Description
ALERE NORTH AMERICA, LLC
84R2
In Commercial Distribution

  • 10859035006245 ()
  • 00859035006248 ()


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

Anti-Mycoplasma pneumoniae IFA (IgG) - 04049016055150

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-1005 G
Not in Commercial Distribution

  • 04049016055150 ()


  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Mycoplasma pneumoniae IFA (IgG) - 04049016055143

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

CMV IgG ELISA - 04048474027976

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)

Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit - G5229030011

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

Chlamydia trachomatis / C. trach IgG IFA 96 Test - G5229030001

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

Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit - G5229028011

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

Varicella-Zoster Virus / VZV IgG IFA 96 Test - G5229028001

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

Anti-Mumps Virus AT ELISA (IgG) - 04049016083283

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601-3 G
In Commercial Distribution

  • 04049016083283 ()


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

Avidity: Anti-Measles Virus ELISA (IgG) - 04049016083276

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2610-9601-1 G
Not in Commercial Distribution

  • 04049016083276 ()


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

Elecsys Rubella IgG - 04015630940240

No Description
Roche Diagnostics GmbH
07027770190
In Commercial Distribution

  • 04015630940240 ()
07027770190

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

Elecsys Rubella IgG Immunoassay - 04015630939251

No Description
Roche Diagnostics GmbH
4618793160
In Commercial Distribution

  • 04015630939251 ()
4618793160

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

BioSign® Rubella card - 10743816001034

BioSign® Rubella card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-171-10-01
In Commercial Distribution

  • 10743816001034 ()
BSP-171-10-01

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

BioSign® Rubella card - 10743816001027

BioSign® Rubella card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-171-35-01
In Commercial Distribution

  • 10743816001027 ()
BSP-171-35-01

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

Biotrin Parvovirus B19 IgG EIA - 08056771103343

No Description
DIASORIN SPA
V519IGUS
In Commercial Distribution



  • Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

LIAISON® MUREX Control HCV Ab - 08056771500227

No Description
DIASORIN S.P.A.
318241
In Commercial Distribution

  • 08056771500227 ()
  • 28056771500221 ()


  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD, control

ASI Mumps IgG EIA Test - 00816057020614

Detection of Mumps antibody
ARLINGTON SCIENTIFIC, INC.
NC-860096-AG
In Commercial Distribution

  • 00816057020614 ()

  • 96 Test
NC-860096-AG

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

ASI Measles IgG EIA Test - 00816057020591

Detection of Measles Antibody
ARLINGTON SCIENTIFIC, INC.
NC-850096-AG
In Commercial Distribution

  • 00816057020591 ()

  • 96 Test
NC-850096-AG

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

ASI CMV IgG EIA Test - 00816057020553

Detection of CMV Antibody
ARLINGTON SCIENTIFIC, INC.
NC-820096-AG
In Commercial Distribution

  • 00816057020553 ()

  • 96 Test
NC-820096-AG

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ASI Rubella IgG EIA Test - 00816057020515

Detection of Rubella Virus Antiboby
ARLINGTON SCIENTIFIC, INC.
NC-800096-AG
In Commercial Distribution

  • 00816057020515 ()

  • 96 Test
NC-800096-AG

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

Mycobacterium tuberculosis Control Slides - B502BSB29980

Mycobacterium tuberculosis, Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB29980 ()
BSB 2998

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, control

RSV Negative Control - B110RSN90100

No Description
Bion Enterprises, Ltd.
RSN-9010
In Commercial Distribution

  • B110RSN90100 ()
RSN-9010

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control

RSV IgG Control - B110RSG90200

No Description
Bion Enterprises, Ltd.
RSG-9020
In Commercial Distribution

  • B110RSG90200 ()
RSG-9020

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, control

Pointe Scientific, Inc. CMV IgG - 00811727015198

Pointe Scientific, Inc. CMV IgG Reagent is for the detection of human IgG antibodies to cytomegalovirus virus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8005-96
In Commercial Distribution

  • 00811727015198 ()
T8005-96

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Pointe Scientific, Inc. Rubella IgG - 00811727015174

Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8003-96
In Commercial Distribution

  • 00811727015174 ()
T8003-96

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

Chlamydia Trachomatis IgG 120 Test Kit - 00813545025519

No Description
SCIMEDX CORPORATION
I-CTR01G
In Commercial Distribution

  • 00813545025519 ()
I-CTR01G

  • Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit - B3507205400

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)

Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit - B3507205200

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)

Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit - B3507203600

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)

Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit - B3507203200

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)

Rubella IgG AccuBind ELISA Test System - 192 Wells - 00816870024172

No Description
MONOBIND, INC.
6325-300
In Commercial Distribution

  • 00816870024172 ()

  • Width: 7.75 Inch
6325-300B

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

Rubella IgG AccuBind ELISA Test System - 96 Wells - 00816870024165

No Description
MONOBIND, INC.
6325-300
In Commercial Distribution

  • 00816870024165 ()

  • Width: 7.75 Inch
6325-300A

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

CMV IgG AccuBind ELISA Test System - 192 Wells - 00816870024257

No Description
MONOBIND, INC.
6525-300
In Commercial Distribution

  • 00816870024257 ()

  • Width: 7.75 Inch
6525-300B

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CMV IgG AccuBind ELISA Test System - 96 Wells - 00816870024240

No Description
MONOBIND, INC.
6525-300
In Commercial Distribution

  • 00816870024240 ()

  • Width: 7.75 Inch
6525-300A

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diamedix - 00817273020396

"720-790 ANA ELISA Screen Test Kit"
DIAMEDIX CORPORATION
720-790
In Commercial Distribution

  • 00817273020396 ()


  • Candida albicans immunoglobulin G (IgG) antibody IVD, control

Diamedix - 00817273020303

"720-540 Mumps IgG Test Kit"
DIAMEDIX CORPORATION
720-540
In Commercial Distribution

  • 00817273020303 ()


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

Diamedix - 00817273020297

"720-520 Measles IgG Test Kit"
DIAMEDIX CORPORATION
720-520
In Commercial Distribution

  • 00817273020297 ()


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

Diamedix - 00817273020228

"720-400 anti-Cardiolipin IgG/IgM Test Kit"
DIAMEDIX CORPORATION
720-400
In Commercial Distribution

  • 00817273020228 ()


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

Diamedix - 00817273020211

"720-380 VZV IgG Test Kit"
DIAMEDIX CORPORATION
720-380
In Commercial Distribution

  • 00817273020211 ()


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

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
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