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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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IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 - 00630414984575

Specific IgE D2 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485105
In Commercial Distribution

  • 00630414984575 ()
DC2LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 - 00630414984568

Specific IgE D1 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485104
In Commercial Distribution

  • 00630414984568 ()
DC1LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE® 2000 ALLERGEN SPE Allergen Specific IgE CVM - 00630414979519

Allergen Specific IgE CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388502
In Commercial Distribution

  • 00630414979519 ()
L2UNCVM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005759

Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005742

Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000143
In Commercial Distribution

  • 00847661005742 ()
12000143

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005735

Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000142
In Commercial Distribution

  • 00847661005735 ()
12000142

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005728

Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000141
In Commercial Distribution

  • 00847661005728 ()
12000141

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

BioFire JI Control Panel M420 - 00852720008121

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008121 ()
M420

  • Escherichia coli nucleic acid IVD, control

IgE Extended Calibrator Set - 00816879022094

No Description
HYCOR BIOMEDICAL LLC
74129
Not in Commercial Distribution

  • 00816879022094 ()
74129

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator

Specific IgE calibrator set - 00816879022087

No Description
HYCOR BIOMEDICAL LLC
74119
Not in Commercial Distribution

  • 00816879022087 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator
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