Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06419587010205
- Basic UDI-DI Code
- B-06419587010205
- Reference
- 601020.02
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
Pepsinogen II (PGII) test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human pepsinogen II from EDTA plasma or serum samples. The test aids in diagnosis of atrophic gastritis in the gastric corpus from the patients at risk to develop malignant cellular changes in stomach mucosa, with the Pepsinogen I test (REF 601010.01) by a PGI/PGII ratio. Furthermore, PGII is used for screening of mucosal inflammation. 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 |
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