H. PYLORI DETECTION BY NA REAGENTS
Basic Information
- Primary DI
- 04049095161742
- Basic UDI-DI Code
- 4049095PM23050000JU
- Reference
- PM2305
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- R-Biopharm AG
Additional Description
For in vitro diagnostic use. The RIDAยฎPrime H. pylori BDM test, which can be performed manually or automatically, is a multiplex real-time PCR for the direct qualitative detection of Helicobacter pylori DNA and the DNA of clarithromycin resistance (mutations A2142G, A2142C, and A2143G) in untreated human biopsy samples from people with signs and symptoms of acute gastroenteritis. The RIDAยฎPrime H. pylori BDM test is intended to support the diagnosis of Helicobacter pylori infection and any clarithrornvcin resistance (mutations A2142G, A2142C, and A2143G) in patients with symptoms of gastric disease in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with Helicobacter pylori or the presence of clarithromycin resistance and should not be used as the sole basis for diagnosis. The product is intended for professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010403 | H. PYLORI DETECTION BY NA REAGENTS |
Available In Countries
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