Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

PEPSINOGEN

Changsha Sinocare Inc. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-02B0026YT
Basic UDI-DI Code
B-02B0026YT
Reference
2X001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

The PGⅠ/PGⅡ Reagent Kit is intended to quantitatively determine PGⅠ or PGⅡ in human serum. Clinically, it is mainly used for auxiliary evaluation of secretory function of the gastric gland cells and auxiliary diagnosis of atrophic gastritis. PG is an inactive precursor of pepsin in gastric juice and classified into PGI and PGII subtypes based on differences in distribution and immunogen. PG serum level reflects the morphology and function of gastric mucosa in different parts. PGI serves as an indication to detect the secretory function of the gastric gland cells, whose increase is accompanied by increased gastric acid secretion, while its decrease is witnessed upon gastric acid secretion reduction or gastric mucosal gland atrophy. PGII is greatly correlated with gastric fundus mucosal lesions, and its increase is accompanied with gastric fundus glandular duct atrophy, intestinal epithelial metaplasia or pseudopyloric gland metaplasia, and heterosexual hyperplasia. The progressive decrease of PGI / PGII ratio is associated with the progression of gastric mucosal atrophy.

CND Nomenclature Codes

Code Description
W0102069006 PEPSINOGEN

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