Australia - English - Department of Health (Therapeutic Goods Administration)

medical diagnostics australasia pty ltd - urea(13c), quantity: 50 mg - tablet, uncoated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; purified talc; microcrystalline cellulose; citric acid - this medicinal product is for diagnostic use only. diabact ubt is for in vivo diagnosis of gastroduodenal helicobacter pylori infection.

Australia - English - Department of Health (Therapeutic Goods Administration)

medical diagnostics australasia pty ltd - urea(13c), quantity: 50 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; citric acid; purified talc; croscarmellose sodium; magnesium stearate - this medicinal product is for diagnostic use only. diabact ubt is for in vivo diagnosis of gastroduodenal helicobacter pylori infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

breath testing services limited - urea 100mg - tablet - 100 mg - active: urea 100mg excipient: colloidal silicon dioxide microcrystalline cellulose povidone sodium benzoate

United States - English - NLM (National Library of Medicine)

meridian bioscience israel ltd - urea c-13 (unii: w6kx9e6d8x) (urea c-13 - unii:w6kx9e6d8x), citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl) - citric acid 4 g - the exalenz breathid® breath test system is intended for use in the qualitative detection of urease associated with helicobacter pylori (h. pylori ) in the human stomach and as an aid in the initial diagnosis and post treatment monitoring of h. pylori infection in adult patients. this test should be used after at least four weeks of h. pylori eradication therapy. for these purposes, the system utilizes molecular correlation spectrometry (mcs™) for the measurement of the ratio of 13co2 to 12co2 in breath samples. the exalenz breathid® system is used to detect and monitor h. pylori infection by measuring changes in the 13 co2 to 12 co2 ratio in a patient’s breath following the ingestion of 13 c-urea.the exalenz breathid® breath test system consists of the idkit: hp™ kits containing 13c-urea tablet, 75 mg for oral solution and 4.3 g citrica powder (4g citric acid) for oral solution; the breathid® device and the idcheck™ system quality control accessory.the device is for use by trained healthcare professiona

European Union - English - EMA (European Medicines Agency)

infai, institut für biomedizinische analytik nmr-imaging gmbh - urea (13c) - breath tests; helicobacter infections - diagnostic agents - 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.

European Union - English - EMA (European Medicines Agency)

torbet laboratories ireland limited - urea (13c) - breath tests; helicobacter infections - diagnostic agents - this medicinal product is for diagnostic use only.for in vivo diagnosis of gastroduodenal helicobacter pylori (h. pylori) infection.

Ireland - English - HPRA (Health Products Regulatory Authority)

kibion ab - 13c-urea - tablet - 50 milligram(s) - other diagnostic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoires mayoly spindler - 13c-urea - tablet - 50 milligram(s) - other diagnostic agents

Singapore - English - HSA (Health Sciences Authority)

nagase singapore (pte) ltd - 13c urea - tablet - 100mg - 13c urea 100mg

Australia - English - Department of Health (Therapeutic Goods Administration)

urea(13c); 13c-urea or urea [13c] -