Basic Information
- Primary DI
- 06419587010106
- Basic UDI-DI Code
- B-06419587010106
- Reference
- 601010.01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
Pepsinogen I (PGI) test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human pepsinogen I from EDTA plasma or serum samples. The test aids in diagnosis of an advanced atrophic gastritis in the gastric corpus from the patients at risk to develop malignant cellular changes in stomach mucosa. In addition, it aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa. Pepsinogen I test can also be used together with the Pepsinogen II test (REF 601020.02) by which the PGI/PGII ratio is determined. The test can be conducted either manually or automatically and is to be used by healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102019099 | SPECIFIC PROTEINS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).