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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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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

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

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

Validate - 00850011135549

Toxoplasma IgG Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
803re
In Commercial Distribution

  • 00850011135549 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

Validate - 00850011135495

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

Bio-Rad Laboratories, Inc. - 00847865010757

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)

BioPlex 2200 - 00847865000260

Syphilis IgG Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6631420
In Commercial Distribution

  • 00847865000260 ()

  • 1 Each
6631420

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, calibrator

BioPlex 2200 - 00847865000253

Syphilis IgG Calibrator Set
BIO-RAD LABORATORIES, INC.
6631400
In Commercial Distribution

  • 00847865000253 ()

  • Total Volume: 0.5 Milliliter
  • 4 Vials
6631400

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, calibrator

Atellica IM Toxo G QC - 00630414600130

Toxoplasma G - IgG (ToxG) QC Kit Atellica IM - CLT 2 x 2 x 2.7mL
Siemens Healthcare Diagnostics Inc.
10995700
In Commercial Distribution

  • 00630414600130 ()
10995700

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

IMMULITE® TOXOPLASMA QUANT. CVM - 00630414971414

Toxoplasma Quantitative CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373709
In Commercial Distribution

  • 00630414971414 ()
LTXPCVM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur® Toxo G QC - 00630414208756

TOXO IgG - CENTAUR - CONS - 2x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310325
In Commercial Distribution

  • 00630414208756 ()
120382

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems TXP CONTROL Toxoplasma IgG - 00630414976747

Toxoplasma IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469600
In Commercial Distribution

  • 00630414976747 ()
LTXPCM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur Herpes-1 IgG Quality Control - 00630414016757

Herpes-1 IgG (HSV1) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720847
In Commercial Distribution

  • 00630414016757 ()
10720847

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur Herpes-2 IgG Quality Control - 00630414016733

Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720850
In Commercial Distribution

  • 00630414016733 ()
10720850

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

Pseudomonas-CF-IgG kit, ELISA - 05713106647424

Human-antisera, Pseudomonas-CF-IgG
Ssi Diagnostica A/S
64742
Not in Commercial Distribution

  • 05713106647424 ()
64742

  • Pseudomonas aeruginosa immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diptheria Toxoid IgG Low Control - 05051700021005

No Description
THE BINDING SITE GROUP LIMITED
EA070.A
In Commercial Distribution

  • 05051700021005 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diptheria Toxoid IgG High Control - 05051700020992

No Description
THE BINDING SITE GROUP LIMITED
EA069.A
In Commercial Distribution

  • 05051700020992 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Diptheria Toxoid IgG Calibrator Set - 05051700020985

No Description
THE BINDING SITE GROUP LIMITED
EA068.A
In Commercial Distribution

  • 05051700020985 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Tetanus Toxoid IgG Calibrator Set - 05051700019583

No Description
THE BINDING SITE GROUP LIMITED
EA115.A
In Commercial Distribution

  • 05051700019583 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, calibrator

Trinity Biotech - 05391516747066

Captia™ Varicella-Zoster Virus (VZV) IgG
CLARK LABORATORIES, INC.
2325601
In Commercial Distribution

  • 05391516747066 ()

  • 480 Tests
2325601

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

Trinity Biotech - 05391516746359

Uni-Gold™ Cryptosporidium Control, Cryptosporidium Positive and Negative Control, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206621
In Commercial Distribution

  • 05391516746359 ()
1206621

  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, control

TrinityBiotech - 05391516746342

Uni-Gold™ Cryptosporidium, 20 Tests
MARDX DIAGNOSTICS, INC.
1206620
In Commercial Distribution

  • 05391516746342 ()
1206620

  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Trinity Biotech - 05391516743679

Captia™ H. pylori IgG
CLARK LABORATORIES, INC.
2346400
In Commercial Distribution

  • 05391516743679 ()

  • 96 Tests
2346400

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

Trinity Biotech - 05391516743525

Captia™ Varicella-Zoster Virus (VZV) IgG
CLARK LABORATORIES, INC.
2325600
In Commercial Distribution

  • 05391516743525 ()

  • 96 Tests
2325600

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

Trinity Biotech - 05391516747516

Captia H. pylori IgG
CLARK LABORATORIES, INC.
2346401
In Commercial Distribution

  • 05391516747516 ()

  • 480 Tests
2346401

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

Trinity Biotech - 05391516743945

Captia Mycoplasma IgG
CLARK LABORATORIES, INC.
2344800
In Commercial Distribution

  • 05391516743945 ()

  • 96 Tests
2344800

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

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)

ReQuest - 00850487007012

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

  • 00850487007012 ()
Q01-180

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

STRADIS HEALTHCARE - M752ZZ07000

HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control

ELISA H. pylori IgG Smart Kit Test System - 00845533000659

The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM3Z51021G
In Commercial Distribution

  • 00845533000659 ()
SM3Z51021G

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

ELISA H. pylori IgG Q Test System - 00845533000642

The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q3Z51021GB
In Commercial Distribution

  • 00845533000642 ()
Q3Z51021GB

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

ELISA H. pylori IgG Bulk Test System - 00845533000635

The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z51021GB
In Commercial Distribution

  • 00845533000635 ()
3Z51021GB

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

ELISA H. pylori IgG Test System - 00845533000628

The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
3Z51021G
In Commercial Distribution

  • 00845533000628 ()
3Z51021G

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

ImmunoFA Toxoplasma IgG High Control - 00613745012056

Positive control for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1205
In Commercial Distribution

  • 00613745012056 ()

  • 1.0 mL
1205

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

ImmunoFA Toxoplasma IgG Low Control - 00613745012049

Positive Control for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1204
In Commercial Distribution

  • 00613745012049 ()

  • 1.0 mL
1204

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

QUANTA Lite® H.pylori IgG ELISA - 08426950593256

1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgG ELISA Low Positive 4. 1x 1.2mL prediluted H. pylori IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708715
In Commercial Distribution

  • 08426950593256 ()


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

GAP®-IgG (Gastritis and Peptic Ulcer Test) - 08305900070040

The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori.
BIOMERICA, INC.
7004
Not in Commercial Distribution

  • 08305900070040 ()


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

LIAISON® Control HSV-1 IgG - 08056771600248

No Description
Diasorin Inc.
310831
In Commercial Distribution

  • 08056771600248 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control

LIAISON® Control HSV-2 IgG - 08056771600118

No Description
Diasorin Inc.
310621
In Commercial Distribution

  • 08056771600118 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control

LIAISON® MUREX HCV Ab - 08056771500197

No Description
DIASORIN S.P.A.
318240
In Commercial Distribution

  • 08056771500197 ()
  • 18056771500194 ()


  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Aquaporin-4 Auto-Antibody (AQP4Ab) - B126KR82000

An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum.
KRONUS, INC.
KR8200
In Commercial Distribution

  • B126KR82000 ()
KR8200

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

Zinc Transporter 8 Auto-Antibody (ZnT8) - B126KR77300

An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum.
KRONUS, INC.
KR7730
In Commercial Distribution

  • B126KR77300 ()
KR7730

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT - B126KR71100

An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
KRONUS, INC.
KR7110
In Commercial Distribution

  • B126KR71100 ()
KR7110

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

KRONUS 21-OH Autoantibody (21-OH) ELISA Kit - B126KR70150

An enzyme linked immunosorbent assay for the qualitative determination of autoantibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR7015
In Commercial Distribution

  • B126KR70150 ()
KR7015

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
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