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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
Zimmer, Inc.
00-5755-015-05
In Commercial Distribution

  • 00889024191655 ()

  • Size E Minus (E-)
00-5755-015-05

  • Knee femur prosthesis trial, reusable
No Description
Zimmer, Inc.
00-5752-015-06
In Commercial Distribution

  • 00889024191426 ()

  • Size E Minus, (E-)
00-5752-015-06

  • Coated knee femur prosthesis
No Description
Zimmer, Inc.
00-5752-015-05
In Commercial Distribution

  • 00889024191419 ()

  • Size E Minus, (E-)
00-5752-015-05

  • Coated knee femur prosthesis
No Description
Zimmer, Inc.
00-5750-015-06
In Commercial Distribution

  • 00889024191228 ()

  • Size E Minus, (E-)
00-5750-015-06

  • Uncoated knee femur prosthesis, metallic
No Description
Zimmer, Inc.
00-5750-015-05
In Commercial Distribution

  • 00889024191211 ()

  • Size E Minus, (E-)
00-5750-015-05

  • Uncoated knee femur prosthesis, metallic
No Description
Zimmer, Inc.
65-5952-15-06
In Commercial Distribution

  • 00889024259638 ()

  • Size E Minus, (E-)
65-5952-015-06

  • Coated knee femur prosthesis
No Description
Zimmer, Inc.
65-5952-15-05
In Commercial Distribution

  • 00889024259621 ()

  • Size E Minus, (E-)
65-5952-015-05

  • Coated knee femur prosthesis
Fluorescein conjugated polyclonal goat antiserum to Human IgE
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761042 ()
104202

  • Total immunoglobulin E (IgE total) IVD, antibody
Goat antiserum to Human IgE
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761040 ()
104002

  • Total immunoglobulin E (IgE total) IVD, antibody
For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE.
KAMIYA BIOMEDICAL COMPANY, LLC
K94C-4M
In Commercial Distribution

  • 00816426021389 ()
K94C-4M

  • Total immunoglobulin E (IgE total) IVD, control
For use as a consistent test sample of known concentration for monitoring assay conditions for Total IgE.
KAMIYA BIOMEDICAL COMPANY, LLC
K94C-2M
Not in Commercial Distribution

  • 00816426021372 ()
K94C-2M

  • Total immunoglobulin E (IgE total) IVD, control
IgE Total CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388001
In Commercial Distribution

  • 00630414973692 ()
LIECVM

  • Total immunoglobulin E (IgE total) IVD, control
IgE Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311621
In Commercial Distribution

  • 00630414126265 ()
672423000

  • Total immunoglobulin E (IgE total) IVD, control
No Description
THE BINDING SITE GROUP LIMITED
PX014
In Commercial Distribution

  • 05051700010122 ()


  • Total immunoglobulin E (IgE total) IVD, antibody
Total IgE (tIgE) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995617
In Commercial Distribution

  • 00630414599403 ()
10995617

  • Total immunoglobulin E (IgE total) IVD, control
Polyclonal Rabbit Anti-Human IgE
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0094
In Commercial Distribution

  • 05700572028543 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin E (IgE total) IVD, antibody
IgE Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB30730 ()
BSB 3073

  • Total immunoglobulin E (IgE total) IVD, control
IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB30720 ()
BSB 3072

  • Total immunoglobulin E (IgE total) IVD, antibody
IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB30710 ()
BSB 3071

  • Total immunoglobulin E (IgE total) IVD, antibody
IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB30700 ()
BSB 3070

  • Total immunoglobulin E (IgE total) IVD, antibody
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