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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

Wellcolex E.coli O157:H7 - 05056080501895

No Description
REMEL EUROPE LIMITED
R30959601
In Commercial Distribution

  • 05056080501895 ()


  • Escherichia coli antigen IVD, kit, agglutination

Wellcolex E.coli O157 - 05056080501888

No Description
REMEL EUROPE LIMITED
R30959501
In Commercial Distribution

  • 05056080501888 ()


  • Escherichia coli antigen IVD, kit, agglutination

Escherichia coli Polyvalent 4 Types O44:K74(L), O112:K66(B11), O124:K72(B17), O1 - 05056080501864

No Description
REMEL EUROPE LIMITED
R30955101
In Commercial Distribution

  • 05056080501864 ()


  • Escherichia coli antigen IVD, kit, agglutination

Escherichia coli Polyvalent 3 Types O86(B7), O114:K90, O125(B15), O127(B8), O128 - 05056080501857

No Description
REMEL EUROPE LIMITED
R30955001
In Commercial Distribution

  • 05056080501857 ()


  • Escherichia coli antigen IVD, kit, agglutination

Escherichia coli Polyvalent 2 Types O26(B6), O55(B5), O111(B4), O119(B14), O126( - 05056080501840

No Description
REMEL EUROPE LIMITED
R30954901
In Commercial Distribution

  • 05056080501840 ()


  • Escherichia coli antigen IVD, kit, agglutination

Poly Rb A-Escherichia Coli - 05700572001690

Polyclonal Rabbit Anti- Escherichia Coli
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
B0357
In Commercial Distribution

  • 05700572001690 ()

  • Total Volume: 2 Milliliter


  • Escherichia coli antigen IVD, antibody

DRYSPOT E. COLI O157 - 05032384034420

No Description
OXOID LIMITED
DR0120M
In Commercial Distribution

  • 05032384034420 ()


  • Escherichia coli antigen IVD, kit, agglutination

E. COLI O157 TEST KIT - 05032384013142

No Description
OXOID LIMITED
DR0620M
In Commercial Distribution

  • 05032384013142 ()


  • Escherichia coli antigen IVD, kit, agglutination

BD Difco™ Escherichia coli H Antiserum H7 - 00382902215912

BD Difco™ Escherichia coli H Antiserum H7
BECTON, DICKINSON AND COMPANY
221591
In Commercial Distribution

  • 00382902215912 ()
221591

  • Escherichia coli antigen IVD, kit, agglutination

BD Difco™ QC Antigen Alkalescens Dispar Group 1 - 00382902211617

BD Difco™ QC Antigen Alkalescens Dispar Group 1
BECTON, DICKINSON AND COMPANY
221161
Not in Commercial Distribution

  • 00382902211617 ()

  • Total Volume: 1 Milliliter
221161

  • Escherichia coli antigen IVD, control

BD Difco™ Escherichia coli O Antiserum O157 - 00382902297017

Difco™ E. Coli O Antiserum O157
BECTON, DICKINSON AND COMPANY
229701
In Commercial Distribution

  • 00382902297017 ()

  • Total Volume: 3 Milliliter
229701

  • Escherichia coli antigen IVD, kit, agglutination

BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1-4 - 00382902283812

BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1–4
BECTON, DICKINSON AND COMPANY
228381
In Commercial Distribution

  • 00382902283812 ()
228381

  • Escherichia coli antigen IVD, antibody

E. coli reference strain O165 - 05713106823019

Reference strain
Ssi Diagnostica A/S
82301
In Commercial Distribution

  • 05713106823019 ()
82301

  • Escherichia coli antigen IVD, control

E. coli reference strain O164 - 05713106823002

Reference strain
Ssi Diagnostica A/S
82300
In Commercial Distribution

  • 05713106823002 ()
82300

  • Escherichia coli antigen IVD, control

E. coli reference strain O163 - 05713106822999

Reference strain
Ssi Diagnostica A/S
82299
In Commercial Distribution

  • 05713106822999 ()
82299

  • Escherichia coli antigen IVD, control

E. coli reference strain O162 - 05713106822982

Reference strain
Ssi Diagnostica A/S
82298
In Commercial Distribution

  • 05713106822982 ()
82298

  • Escherichia coli antigen IVD, control

E. coli reference strain O161 - 05713106822975

Reference strain
Ssi Diagnostica A/S
82297
In Commercial Distribution

  • 05713106822975 ()
82297

  • Escherichia coli antigen IVD, control

E. coli reference strain O160 - 05713106822968

Reference strain
Ssi Diagnostica A/S
82296
In Commercial Distribution

  • 05713106822968 ()
82296

  • Escherichia coli antigen IVD, control

E. coli reference strain O159 - 05713106822951

Reference strain
Ssi Diagnostica A/S
82295
In Commercial Distribution

  • 05713106822951 ()
82295

  • Escherichia coli antigen IVD, control

E. coli reference strain O158 - 05713106822937

Reference strain
Ssi Diagnostica A/S
82293
In Commercial Distribution

  • 05713106822937 ()
82293

  • Escherichia coli antigen IVD, control

E. coli reference strain O157 - 05713106822920

Reference strain
Ssi Diagnostica A/S
82292
In Commercial Distribution

  • 05713106822920 ()
82292

  • Escherichia coli antigen IVD, control

E. coli reference strain O156 - 05713106822913

Reference strain
Ssi Diagnostica A/S
82291
In Commercial Distribution

  • 05713106822913 ()
82291

  • Escherichia coli antigen IVD, control

E. coli reference strain O155 - 05713106822906

Reference strain
Ssi Diagnostica A/S
82290
In Commercial Distribution

  • 05713106822906 ()
82290

  • Escherichia coli antigen IVD, control

E. coli reference strain O154 - 05713106822890

Reference strain
Ssi Diagnostica A/S
82289
In Commercial Distribution

  • 05713106822890 ()
82289

  • Escherichia coli antigen IVD, control

E. coli reference strain O153 - 05713106822883

Reference strain
Ssi Diagnostica A/S
82288
In Commercial Distribution

  • 05713106822883 ()
82288

  • Escherichia coli antigen IVD, control

E. coli reference strain O152 - 05713106822876

Reference strain
Ssi Diagnostica A/S
82287
In Commercial Distribution

  • 05713106822876 ()
82287

  • Escherichia coli antigen IVD, control

E. coli reference strain O151 - 05713106822869

Reference strain
Ssi Diagnostica A/S
82286
In Commercial Distribution

  • 05713106822869 ()
82286

  • Escherichia coli antigen IVD, control

E. coli reference strain O150 - 05713106822852

Reference strain
Ssi Diagnostica A/S
82285
In Commercial Distribution

  • 05713106822852 ()
82285

  • Escherichia coli antigen IVD, control

E. coli reference strain O149 - 05713106822845

Reference strain
Ssi Diagnostica A/S
82284
In Commercial Distribution

  • 05713106822845 ()
82284

  • Escherichia coli antigen IVD, control

E. coli reference strain O148 - 05713106822838

Reference strain
Ssi Diagnostica A/S
82283
In Commercial Distribution

  • 05713106822838 ()
82283

  • Escherichia coli antigen IVD, control

E. coli reference strain O147 - 05713106822821

Reference strain
Ssi Diagnostica A/S
82282
In Commercial Distribution

  • 05713106822821 ()
82282

  • Escherichia coli antigen IVD, control

E. coli reference strain O146 - 05713106822814

Reference strain
Ssi Diagnostica A/S
82281
In Commercial Distribution

  • 05713106822814 ()
82281

  • Escherichia coli antigen IVD, control

E. coli reference strain O145 - 05713106822807

Reference strain
Ssi Diagnostica A/S
82280
In Commercial Distribution

  • 05713106822807 ()
82280

  • Escherichia coli antigen IVD, control

E. coli reference strain O142 - 05713106822777

Reference strain
Ssi Diagnostica A/S
82277
In Commercial Distribution

  • 05713106822777 ()
82277

  • Escherichia coli antigen IVD, control

E. coli reference strain O141ab - 05713106822746

Reference strain
Ssi Diagnostica A/S
82274
In Commercial Distribution

  • 05713106822746 ()
82274

  • Escherichia coli antigen IVD, control

E. coli reference strain O135 - 05713106822685

Reference strain
Ssi Diagnostica A/S
82268
In Commercial Distribution

  • 05713106822685 ()
82268

  • Escherichia coli antigen IVD, control

E. coli reference strain O134 - 05713106822678

Reference strain
Ssi Diagnostica A/S
82267
In Commercial Distribution

  • 05713106822678 ()
82267

  • Escherichia coli antigen IVD, control

E. coli reference strain O133 - 05713106822661

Reference strain
Ssi Diagnostica A/S
82266
In Commercial Distribution

  • 05713106822661 ()
82266

  • Escherichia coli antigen IVD, control

E. coli reference strain O131 & H26 - 05713106821428

Reference strain
Ssi Diagnostica A/S
82142
In Commercial Distribution

  • 05713106821428 ()
82142

  • Escherichia coli antigen IVD, control

E. coli reference strain O130 - 05713106821411

Reference strain
Ssi Diagnostica A/S
82141
In Commercial Distribution

  • 05713106821411 ()
82141

  • Escherichia coli antigen IVD, control
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