Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

GastroPanel® Gastrin-17 — IVDD — General IVDD by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Aug 26, 2022

GastroPanel® Gastrin-17

B-06419587060354

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587060354
Reference / catalog number: 606035

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: GastroPanel® Gastrin-17
UDI-DI code: 06419587060354
Basic UDI-DI: B-06419587060354
Reference / catalog number: 606035
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: GastroPanel Gastrin (G-17) test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human gastrin-17 from EDTA plasma samples and is intended to be used in conjunction with the other tests of GastroPanel Unified (REF 606400): GastroPanel Pepsinogen I (REF 606010), GastroPanel Pepsinogen II (REF 606020) and GastroPanel Helicobacter pylori (REF 606040). The dedicated software GastroSoft can be used for result interpretation and reporting of all four tests of GastroPanel Unified. Test can be conducted either manually or automatically by the healthcare professionals. GastroPanel Unified test is intended for diagnosing H. pylori infection and atrophic gastritis (AG) from patients with dyspeptic symptoms or at risk to develop malignant cellular changes in stomach mucosa. In addition, GastroPanel Unified test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa as well as GastroPanel Gastrin-17 test. G-17 is a direct biomarker of antral structure and function, and an indirect biomarker of gastric corpus. Furthermore, GastroPanel Gastrin-17 test is intended for screening and monitoring the acid output of the stomach.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021499MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Acetium 100 mgB-620000CWQOn the market Acetium lozenge - quit smokingB-620000LXAOn the market BIOHIT Active B12 (HoloTC)B-06419587022901On the market BIOHIT CalprotectinB-06419587022604On the market BIOHIT Celiac quick testB-06419587020808On the market

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.