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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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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

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

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

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

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

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

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

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

ADVIA Centaur® tIgE - 00630414177489

IgE - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309986
In Commercial Distribution

  • 00630414177489 ()
  • 00630414003269 ()
110778

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

ADVIA Centaur® tIgE - 00630414177472

IgE - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309985
In Commercial Distribution

  • 00630414177472 ()
110777

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

Atellica IM tIgE - 00630414599380

IgE (tIgE) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995615
In Commercial Distribution

  • 00630414599380 ()
10995615

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

Atellica IM tIgE - 00630414599373

IgE (tIgE) Atellica IM – RGT 250T
Siemens Healthcare Diagnostics Inc.
10995614
In Commercial Distribution

  • 00630414599373 ()
  • 00630414007601 ()
10995614

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

GC Plastic Syringe - 10386040006309

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

  • 00386040006302 ()
  • 10386040006309 ()
159310

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - 10386040006286

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

  • 00386040006289 ()
  • 10386040006286 ()
159300

  • Haemoglobin E (HbE) IVD, calibrator

GC Plastic Syringe - 10386040004121

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

  • 00386040004124 ()
  • 10386040004121 ()
159225

  • Haemoglobin E (HbE) IVD, calibrator

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
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