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1. Urea-13c
2. 58069-82-2
3. Urea C 13
4. 13c-urea
5. Urea, C-13
6. Carbon-13 Urea
7. Urea (13c)
8. Diamino(113c)methanone
9. Urea 13 C
10. Helicosol
11. 13-c Urea
12. 13-c-urea
13. Carbone (13) Urea
14. (13c) Urea
15. Urea ((sup 13)c)
16. W6kx9e6d8x
17. Chebi:32285
18. Carbamide-13c
19. Pylobactell
20. Urea (13c) (jan)
21. Urea (13c) [jan]
22. C13-urea
23. Urea C13
24. Helicobacter Test Infai
25. Unii-w6kx9e6d8x
26. Urea C 13 [usp]
27. Pylori-chek
28. Helicosol (tn)
29. Carbon 13 Urea
30. Carbonyldiamide-13c
31. (13c)urea
32. Urea C13 (usp)
33. ((13)c)urea
34. Urea-[13c]
35. (~13~c)carbamimidic Acid
36. Chembl2096648
37. Urea 13 C [who-dd]
38. Urea C 13 [usp-rs]
39. 13-c Urea [ema Epar]
40. Dtxsid20973641
41. Urea C-13 [orange Book]
42. Amy37002
43. Urea C 13 [usp Impurity]
44. Urea C 13 [usp Monograph]
45. Mfcd00064398
46. Akos030254865
47. Idkit:hp Component Urea C-13
48. Db09510
49. Urea C-13 Component Of Idkit:hp
50. As-77784
51. C-13
52. Hy-118877
53. Urea-13c, 99 Atom % 13c, Ubt Grade
54. Cs-0069967
55. Urea-13c, Research Grade, 99 Atom % 13c
56. D01749
57. Q27114855
58. Urea C 13, United States Pharmacopeia (usp) Reference Standard
| Molecular Weight | 61.048 g/mol |
|---|---|
| Molecular Formula | CH4N2O |
| XLogP3 | -1.4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 0 |
| Exact Mass | 61.035717591 g/mol |
| Monoisotopic Mass | 61.035717591 g/mol |
| Topological Polar Surface Area | 69.1 Ų |
| Heavy Atom Count | 4 |
| Formal Charge | 0 |
| Complexity | 29 |
| Isotope Atom Count | 1 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Urea-13C is indicated for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four (4) weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.
FDA Label
This medicinal product is for diagnostic use only.
For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:
- adults;
- adolescents, who are likely to have peptic ulcer disease.
Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection:
- for the evaluation of the success of eradication treatment, or;
- when invasive tests cannot be performed, or;
- when there are discordant results arising from invasive tests.
This medicinal product is for diagnostic use only.
Pylori-Chek may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection.
V04CX
V04CX
V04CX
V - Various
V04 - Diagnostic agents
V04C - Other diagnostic agents
V04CX - Other diagnostic agents
V04CX05 - 13C-urea
The Urea Breath Test is based on the ability of the H. pylori enzyme urease to cleave urea into ammonia and carbon dioxide. As the urease enzyme is not present in mammalian cells, the presence of urease (and the products of urea cleavage) in the stomach is evidence that H. pylori bacteria are present. To detect H. pylori, urea labeled with 13C is swallowed by the patient. If gastric urease from H. pylori is present, urea is split to form CO2 and NH3 at the interface between the gastric epithelium and lumen and 13CO2 is absorbed into the blood and exhaled in the breath. Exhaled breath samples can then be collected and measured for the presence of radioactivity.
API SUPPLIERS
Registration Number : 221MF10045
Registrant's Address : 3 Highwood Drive, Tewksbury, MA 01876, USA
Initial Date of Registration : 2009-02-25
Latest Date of Registration : --
NDC Package Code : 61444-901
Start Marketing Date : 1996-02-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER, FOR SOLUTION (1g/g)
Marketing Category : BULK INGREDIENT
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JDMF
Registration Number : 221MF10045
Registrant's Address : 3 Highwood Drive, Tewksbury, MA 01876, USA
Initial Date of Registration : 2009-02-25
Latest Date of Registration : 2018-11-16
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Sweden
Brand Name : Diabact UBT
Dosage Form : TABLET
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
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
Portfolio PDF
Product Web Link
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Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
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
Portfolio PDF
Product Web Link
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Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
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
Portfolio PDF
Product Web Link
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Regulatory Info :
Registration Country : Italy
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code :
Brand Name : IDKIT:HP
Dosage Form : FOR SOLUTION, TABLET, FOR SOLUTION;ORAL
Dosage Strength : 4GM;75MG
Approval Date : 2002-12-17
Application Number : 21314
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : HELICOSOL
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 125MG/VIAL
Approval Date : 1999-12-17
Application Number : 21092
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : MERETEK UBT KIT (W/ PRANACTIN)
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 125MG/VIAL
Approval Date : 1996-09-17
Application Number : 20586
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : BREATHTEK UBT FOR H-PYLORI
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : EQ 75MG/POUCH
Approval Date : 2001-05-10
Application Number : 20586
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PYLORI-CHEK BREATH TEST
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 100MG/VIAL
Approval Date : 1999-02-04
Application Number : 20900
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Sweden
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Pylobactell
Dosage Form : LÖSLIG TABLETT
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
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Corporate PDF
Regulatory Info :
Registration Country : Italy
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
Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
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
Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
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
Portfolio PDF
Product Web Link
Virtual Booth
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Corporate PDF
Regulatory Info :
Registration Country : Spain
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
Portfolio PDF
Product Web Link
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