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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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Prolex E. coli O157 Latex Test Reagent Kit (100 tests) - 10628429001056

ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls.
PRO-LAB, INCORPORATED
PL.071B
In Commercial Distribution

  • 10628429001056 ()
PL.071B

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O157 Latex Test Reagent Kit (50 tests) - 10628429001049

ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls.
PRO-LAB, INCORPORATED
PL.070B
In Commercial Distribution

  • 10628429001049 ()
PL.070B

  • Escherichia coli antigen IVD, kit, agglutination

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

E. coli O11 serum, 1 mL - 05713106850077

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
85007
In Commercial Distribution

  • 05713106850077 ()
85007

  • Escherichia coli antigen IVD, antibody

E. coli O9 serum, 1 mL - 05713106850053

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
85005
Not in Commercial Distribution

  • 05713106850053 ()
85005

  • Escherichia coli antigen IVD, antibody

E. coli O7 serum, 1 mL - 05713106850039

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
85003
In Commercial Distribution

  • 05713106850039 ()
85003

  • Escherichia coli antigen IVD, antibody
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