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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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The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
ZEUS SCIENTIFIC, INC.
Q3Z17601GB
In Commercial Distribution

  • 00845533000918 ()
Q3Z17601GB

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.
ZEUS SCIENTIFIC, INC.
3Z17601G
In Commercial Distribution

  • 00845533000901 ()
3Z17601G

  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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)
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
Uni-Gold™ Cryptosporidium, 20 Tests
MARDX DIAGNOSTICS, INC.
1206620
In Commercial Distribution

  • 05391516746342 ()
1206620

  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
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)
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)
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)
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)
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)
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)
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)
Toxoplasma IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469600
In Commercial Distribution

  • 00630414976747 ()
LTXPCM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Toxoplasma Quantitative CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373709
In Commercial Distribution

  • 00630414971414 ()
LTXPCVM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
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
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
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
No Description
THE BINDING SITE GROUP LIMITED
EA070.A
In Commercial Distribution

  • 05051700021005 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
EA069.A
In Commercial Distribution

  • 05051700020992 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
EA068.A
In Commercial Distribution

  • 05051700020985 ()


  • Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
EA115.A
In Commercial Distribution

  • 05051700019583 ()


  • Clostridium tetani immunoglobulin G (IgG) antibody IVD, calibrator
TOXO IgG - CENTAUR - CONS - 2x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310325
In Commercial Distribution

  • 00630414208756 ()
120382

  • Toxoplasma gondii 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)
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
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
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)
HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control
HSV-1 IgG Controls
Abbott Ireland Diagnostics
04W2012
In Commercial Distribution

  • 00380740213886 ()
04W2012

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
HAVAb IgG II Reagent Kit 200 test
Abbott GmbH
06S9321
In Commercial Distribution

  • 00380740197650 ()
06S9321

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