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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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Elecsys IgE CalSet - 04015630911134

No Description
Roche Diagnostics GmbH
11930427122
In Commercial Distribution

  • 04015630911134 ()
11930427122

  • Plasma protein IVD, calibrator

Elecsys IgE II - 04015630940226

No Description
Roche Diagnostics GmbH
07027516190
In Commercial Distribution

  • 04015630940226 ()
07027516190

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

Elecsys IgE II Immunoassay - 04015630922369

No Description
Roche Diagnostics GmbH
4827031190
In Commercial Distribution

  • 04015630922369 ()
4827031190

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

IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE - 00630414966137

IgE - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380867
In Commercial Distribution

  • 00630414966137 ()
LKIE1

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

IMMULITE® 2000 Systems TIE Total IgE - 00630414966090

IgE - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380872
In Commercial Distribution

  • 00630414966090 ()
L2KIE6

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

IMMULITE® 2000 Systems TIE Total IgE - 00630414966083

IgE - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380873
In Commercial Distribution

  • 00630414966083 ()
L2KIE2

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

IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE Sample Diluent - 00630414954356

IGE total - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386937
In Commercial Distribution

  • 00630414954356 ()
LIEZ

  • Buffered sample diluent IVD

IMMULITE® Systems TIE CONTROL Total IgE - 00630414953458

IgE total - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385349
In Commercial Distribution

  • 00630414953458 ()
IECM

  • Total immunoglobulin E (IgE total) IVD, control

Hytec Specific/Total IgE EIA - 00816879022100

No Description
HYCOR BIOMEDICAL LLC
74154
Not in Commercial Distribution

  • 00816879022100 ()
74154

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

QMedix™ - 00850054026477

QMedix™Total Human IgE ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1801-18
In Commercial Distribution

  • 00850054026477 ()

  • 96 Tests
1801-18

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
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