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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® 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

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
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