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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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NexGen® Gender Solutions® - 00889024191655

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

NexGen® Gender Solutions® - 00889024191426

No Description
Zimmer, Inc.
00-5752-015-06
In Commercial Distribution

  • 00889024191426 ()

  • Size E Minus, (E-)
00-5752-015-06

  • Coated knee femur prosthesis

NexGen® Gender Solutions® - 00889024191419

No Description
Zimmer, Inc.
00-5752-015-05
In Commercial Distribution

  • 00889024191419 ()

  • Size E Minus, (E-)
00-5752-015-05

  • Coated knee femur prosthesis

NexGen® Gender Solutions™ - 00889024191228

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

NexGen® Gender Solutions™ - 00889024191211

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

NexGen® - 00889024259638

No Description
Zimmer, Inc.
65-5952-15-06
In Commercial Distribution

  • 00889024259638 ()

  • Size E Minus, (E-)
65-5952-015-06

  • Coated knee femur prosthesis

NexGen® - 00889024259621

No Description
Zimmer, Inc.
65-5952-15-05
In Commercial Distribution

  • 00889024259621 ()

  • Size E Minus, (E-)
65-5952-015-05

  • Coated knee femur prosthesis

Anti Human IgE FITC - B1761042

Fluorescein conjugated polyclonal goat antiserum to Human IgE
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761042 ()
104202

  • Total immunoglobulin E (IgE total) IVD, antibody

Antiserum to Human IgE (epsilon specific) - B1761040

Goat antiserum to Human IgE
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761040 ()
104002

  • Total immunoglobulin E (IgE total) IVD, antibody

K-ASSAY® Total IgE Control - 00816426021389

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

K-ASSAY® Total IgE Control - 00816426021372

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

IMMULITE® Systems TIE Calibration Verification Material Total IgE - 00630414973692

IgE Total CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388001
In Commercial Distribution

  • 00630414973692 ()
LIECVM

  • Total immunoglobulin E (IgE total) IVD, control

ADVIA Centaur® IgE MCM - 00630414126265

IgE Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311621
In Commercial Distribution

  • 00630414126265 ()
672423000

  • Total immunoglobulin E (IgE total) IVD, control

Sheep Anti-Human IgE Immunofixation Grade - 05051700010122

No Description
THE BINDING SITE GROUP LIMITED
PX014
In Commercial Distribution

  • 05051700010122 ()


  • Total immunoglobulin E (IgE total) IVD, antibody

Atellica IM tIgE MCM - 00630414599403

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

Poly Rb A-Hu IgE - 05700572028543

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 slides - B502BSB30730

IgE Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB30730 ()
BSB 3073

  • Total immunoglobulin E (IgE total) IVD, control

IgE, RPab - B502BSB30720

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, RPab - B502BSB30710

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, RPab - B502BSB30700

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

Tinto IgE, RPab - B502BSB30690

IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB30690 ()
BSB 3069

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE, RPab - B502BSB30680

IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB30680 ()
BSB 3068

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE, RPab - B502BSB30670

IgE is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 1 ml
In Commercial Distribution

  • B502BSB30670 ()
BSB 3067

  • Total immunoglobulin E (IgE total) IVD, antibody

IgE / FITC control slides - B502BSB3011CS0

IgE / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3011CS0 ()
BSB 3011-CS

  • Total immunoglobulin E (IgE total) IVD, control

Tinto IgE / FITC GPab - B502BSB301170

Tinto IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris-Buffered Saline solution (pH 7.2).
BIO SB, INC.
predilute, 7 ml.
In Commercial Distribution

  • B502BSB301170 ()
BSB 3011-7

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE / FITC GPab - B502BSB301130

Tinto IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris-Buffered Saline solution (pH 7.2).
BIO SB, INC.
predilute, 3 ml.
In Commercial Distribution

  • B502BSB301130 ()
BSB 3011-3

  • Total immunoglobulin E (IgE total) IVD, antibody

Tinto IgE / FITC GPab - B502BSB3011150

Tinto IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris-Buffered Saline solution (pH 7.2)
BIO SB, INC.
predilute, 15 ml.
In Commercial Distribution

  • B502BSB3011150 ()
BSB 3011-15

  • Total immunoglobulin E (IgE total) IVD, antibody

IgE / FITC GPab - B502BSB30111

The IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tris Buffered Saline solution (pH 7.2)
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB30111 ()
BSB 3011-1

  • Total immunoglobulin E (IgE total) IVD, antibody

IgE / FITC GPab - B502BSB3011050

IgE/FITC is a purified goat polyclonal antibody labeled with FITC diluted in a Tri-sBuffered Saline solution (pH 7.2).
BIO SB, INC.
concentrate, 0.5 ml.
In Commercial Distribution

  • B502BSB3011050 ()
BSB 3011-05

  • Total immunoglobulin E (IgE total) IVD, antibody

IMMAGE - 15099590227029

IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent
Beckman Coulter, Inc.
474620
In Commercial Distribution

  • 15099590227029 ()
474620

  • Total immunoglobulin E (IgE total) IVD, antibody

Total Immunoglobulin E (IgE) - 15099590701727

Total Immunoglobulin E (IgE) Reagent kit for AU/DxC AU clinical chemistry analyzers.
Beckman Coulter, Inc.
C22529
In Commercial Distribution

  • 15099590701727 ()


  • Total immunoglobulin E (IgE total) IVD, antibody

IgE AccuLite CLIA Test System - 960 Wells - 00816870021959

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021959 ()

  • Width: 12 Inch
2575-300E

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

IgE AccuLite CLIA Test System - 480 Wells - 00816870021942

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021942 ()

  • Width: 12 Inch
2575-300D

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

IgE AccuLite CLIA Test System - 192 Wells - 00816870021935

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021935 ()

  • Width: 7.75 Inch
2575-300B

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

Monobind AccuLite IgE CLIA Kit - 96 Wells - 00816870021928

No Description
MONOBIND, INC.
2575-300
In Commercial Distribution

  • 00816870021928 ()

  • Width: 7.75 Inch
2575-300A

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay

InTray® SMA - B08814230

a selective and differential media for the detection of sorbitol-non-fermenting Escherichia coli serotype O157:H7 associated with hemorrhagic colitis. This medium is also referred to as "MacConkey Sorbitol Agar."
BIO-MED DIAGNOSTICS, INC.
1423
In Commercial Distribution

  • B08814234 ()
  • B08814230 ()
  • B08814232 ()
21-423-001

  • Sorbitol-MacConkey E. coli agar culture medium IVD

GC Plastic Syringe - D6581593001

GC Plastic Syringe Tips, Package of 100
Gc America Inc.
159300
In Commercial Distribution

  • D6581593001 ()
  • D6581593000 ()
159300

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - D6581592251

Plastic Syringe Tips, Type A, Box of 25
Gc America Inc.
159225
In Commercial Distribution

  • D6581592251 ()
  • D6581592250 ()
159225

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - D6581593101

GC Plastic Syringe Tips Package of 10
Gc America Inc.
159310
In Commercial Distribution

  • D6581593101 ()
  • D6581593100 ()
159310

  • Haemoglobin E (HbE) IVD, calibrator

Alinity - 00380740153700

IgE Reagent Kit 200 tests
ABBOTT LABORATORIES
01R1321
In Commercial Distribution

  • 00380740153700 ()
01R1321

  • Total immunoglobulin E (IgE total) IVD, kit, nephelometry/turbidimetry
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