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Organization name
UDI-DI code
Reference / catalog number

Pepsinogen I — IVDD — General IVDD by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Aug 26, 2022

Pepsinogen I

B-06419587010106

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587010106
Reference / catalog number: 601010.01

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Manufacturer information

Organization name: Biohit Oyj
SRN: FI-MF-000014642
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW132
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: Pepsinogen I
UDI-DI code: 06419587010106
Basic UDI-DI: B-06419587010106
Reference / catalog number: 601010.01
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product 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.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102019099SPECIFIC PROTEINS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.