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01 1AB ANALITICA Srl

02 1DXS DEVICES

03 2INFAI

04 3ITC FARMA Srl

05 1Kibion ??AB

06 1Meridian Bioscience

07 1Metabolic Solutions

08 2Otsuka America Pharmaceutical, Inc.

09 1RICHEN CORTEX EUROPE Srl

10 2Sofar Spa

11 1Torbet Laboratories Ltd

12 1Utandningstester i Sverige AB

13 2Blank

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

CITRIC ACID; UREA C-13

Brand Name : IDKIT:HP

Dosage Form : FOR SOLUTION, TABLET, FOR SOLUTION;ORAL

Dosage Strength : 4GM;75MG

Packaging :

Approval Date : 2002-12-17

Application Number : 21314

Regulatory Info : RX

Registration Country : USA

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

UREA C-13

Brand Name : HELICOSOL

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 125MG/VIAL

Packaging :

Approval Date : 1999-12-17

Application Number : 21092

Regulatory Info : DISCN

Registration Country : USA

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

UREA C-13

Brand Name : MERETEK UBT KIT (W/ PRANACTIN)

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 125MG/VIAL

Packaging :

Approval Date : 1996-09-17

Application Number : 20586

Regulatory Info : DISCN

Registration Country : USA

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

UREA C-13

Brand Name : BREATHTEK UBT FOR H-PYLORI

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : EQ 75MG/POUCH

Packaging :

Approval Date : 2001-05-10

Application Number : 20586

Regulatory Info : DISCN

Registration Country : USA

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Expirobacter

Dosage Form : C-13 Urea 100Mg 1 Combined Oral Use

Dosage Strength : 1 CPR 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Expirobacter

Dosage Form : C-13 Urea 100Mg 1 Combined Oral Use

Dosage Strength : 1 cpr solub 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

DXS DEVICES

Country
Antibody Engineering
Not Confirmed
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DXS DEVICES

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Antibody Engineering
Not Confirmed

UREA C-13

Brand Name : PYLORI-CHEK BREATH TEST

Dosage Form : FOR SOLUTION;ORAL

Dosage Strength : 100MG/VIAL

Packaging :

Approval Date : 1999-02-04

Application Number : 20900

Regulatory Info : DISCN

Registration Country : USA

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08

Kibion ??AB

Country
Antibody Engineering
Not Confirmed
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Kibion ??AB

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Antibody Engineering
Not Confirmed

urea (C-13)

Brand Name : Diabact UBT

Dosage Form : TABLET

Dosage Strength : 50 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

INFAI

Country
Antibody Engineering
Not Confirmed
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INFAI

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Antibody Engineering
Not Confirmed

urea (C-13)

Brand Name : Helicobacter Test INFAI

Dosage Form : POWDER FOR ORAL SOLUTION

Dosage Strength : 75 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

INFAI

Country
Antibody Engineering
Not Confirmed
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INFAI

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Antibody Engineering
Not Confirmed

urea (C-13)

Brand Name : Helicobacter Test INFAI for children aged 3 - 11 years

Dosage Form : POWDER FOR ORAL SOLUTION

Dosage Strength : 45 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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11

Utandningstester i Sverige AB

Country
Antibody Engineering
Not Confirmed
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Utandningstester i Sverige AB

Country
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Antibody Engineering
Not Confirmed

urea(C-13)

Brand Name : Helicobacter Test HP-Plus

Dosage Form : LÖSLIG TABLETT OCH PULVER TILL ORAL LÖSNING

Dosage Strength : --

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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12

Torbet Laboratories Ltd

Country
Antibody Engineering
Not Confirmed
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Torbet Laboratories Ltd

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Antibody Engineering
Not Confirmed

urea(C-13)

Brand Name : Pylobactell

Dosage Form : LÖSLIG TABLETT

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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13

ITC FARMA Srl

Country
Antibody Engineering
Not Confirmed
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ITC FARMA Srl

Country
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 37.5 Mg 2 Units' Oral Use

Dosage Strength : 2 CPR 37.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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14

ITC FARMA Srl

Country
Antibody Engineering
Not Confirmed
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ITC FARMA Srl

Country
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 75Mg 1 Combined Oral Use

Dosage Strength : 1 CPR 75 mg + Kit

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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15

RICHEN CORTEX EUROPE Srl

Country
Antibody Engineering
Not Confirmed
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RICHEN CORTEX EUROPE Srl

Country
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Citredici Ubt Kit

Dosage Form : C-13 Urea 75Mg 1 Combined Oral Use

Dosage Strength : 1 bottle os 75 mg + 1 envelope

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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16

AB ANALITICA Srl

Country
Antibody Engineering
Not Confirmed
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AB ANALITICA Srl

Country
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Breathquality-Ubt

Dosage Form : C-13 Urea 75Mg 10Ml Oral Use

Dosage Strength : os soluz 75 mg 10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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17

ITC FARMA Srl

Country
Antibody Engineering
Not Confirmed
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ITC FARMA Srl

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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Helicokit

Dosage Form : C-13 Urea 75Mg 18 Units Of Oral Use

Dosage Strength : 18 CPR 75 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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18

Country
Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : Tau-Kit 100Mg 1 Pills Soluble

Dosage Form : Tablet

Dosage Strength : 100 Mg/Tablet

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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19

Country
Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

Urea C13

Brand Name : 1 Ubtest 100Mg Film-Coated Tablet

Dosage Form : Film Coated Tablet

Dosage Strength : 100 Mg/Film Coated Tablet

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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