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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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E. coli O157 Antiserum (3ml) - 10628429001216

E. coli O157 Antiserum (3ml)
PRO-LAB, INCORPORATED
PL.6250
In Commercial Distribution

  • 10628429001216 ()
PL.6250

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O91 Latex Reagent - 10628429001209

Prolex E. coli O91 Latex Reagent
PRO-LAB, INCORPORATED
PL.1078
In Commercial Distribution

  • 10628429001209 ()
PL.1078

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli Non-O157 Negative Control Latex Reagent - 10628429001193

Prolex E. coli Non-O157 Negative Control Latex Reagent
PRO-LAB, INCORPORATED
PL.1077
In Commercial Distribution

  • 10628429001193 ()
PL.1077

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O145 Latex Reagent - 10628429001186

Prolex E. coli O145 Latex Reagent
PRO-LAB, INCORPORATED
PL.1076
In Commercial Distribution

  • 10628429001186 ()
PL.1076

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O121 Latex Reagent - 10628429001179

Prolex E. coli O121 Latex Reagent
PRO-LAB, INCORPORATED
PL.1075
In Commercial Distribution

  • 10628429001179 ()
PL.1075

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O111 Latex Reagent - 10628429001162

Prolex E. coli O111 Latex Reagent
PRO-LAB, INCORPORATED
PL.1074
In Commercial Distribution

  • 10628429001162 ()
PL.1074

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O103 Latex Reagent - 10628429001155

Prolex E. coli O103 Latex Reagent
PRO-LAB, INCORPORATED
PL.1073
In Commercial Distribution

  • 10628429001155 ()
PL.1073

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O45 Latex Reagent - 10628429001148

Prolex E. coli O45 Latex Reagent
PRO-LAB, INCORPORATED
PL.1072
In Commercial Distribution

  • 10628429001148 ()
PL.1072

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O26 Latex Reagent - 10628429001131

Prolex E. coli O26 Latex Reagent
PRO-LAB, INCORPORATED
PL.1071
In Commercial Distribution

  • 10628429001131 ()
PL.1071

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli Non-O157 Identification Kit - 10628429001124

The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks.
PRO-LAB, INCORPORATED
PL.1070
In Commercial Distribution

  • 10628429001124 ()
PL.1070

  • Escherichia coli antigen IVD, kit, agglutination

Prolex E. coli O157 Latex Reagent Control Negative - 10628429001100

Negative Control Latex Reagent
PRO-LAB, INCORPORATED
PL.076B
In Commercial Distribution

  • 10628429001100 ()
PL.076B

  • Escherichia coli antigen IVD, kit, agglutination

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

E. coli O5 serum, 1 mL - 05713106850015

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
85001
In Commercial Distribution

  • 05713106850015 ()
85001

  • Escherichia coli antigen IVD, antibody

E. coli O3 serum, 1 mL - 05713106849996

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
84999
In Commercial Distribution

  • 05713106849996 ()
84999

  • Escherichia coli antigen IVD, antibody

E. coli O2 serum, 1 mL - 05713106849989

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
84998
In Commercial Distribution

  • 05713106849989 ()
84998

  • Escherichia coli antigen IVD, antibody

E. coli O1 serum, 1 mL - 05713106849972

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
84997
In Commercial Distribution

  • 05713106849972 ()
84997

  • Escherichia coli antigen IVD, antibody

E. coli O187 serum, 1 mL - 05713106849965

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
84996
In Commercial Distribution

  • 05713106849965 ()
84996

  • 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 O159 - 05713106822951

Reference strain
Ssi Diagnostica A/S
82295
In Commercial Distribution

  • 05713106822951 ()
82295

  • 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 O154 - 05713106822890

Reference strain
Ssi Diagnostica A/S
82289
In Commercial Distribution

  • 05713106822890 ()
82289

  • 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 O150 - 05713106822852

Reference strain
Ssi Diagnostica A/S
82285
In Commercial Distribution

  • 05713106822852 ()
82285

  • 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
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