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

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Organization name
UDI-DI code
Reference / catalog number

GastroPanel® Stabilizer — IVDD — General IVDD by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Aug 26, 2022

GastroPanel® Stabilizer

B-06419587606057

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587606057
Reference / catalog number: 606050

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Manufacturer information

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

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.

Critical warnings

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

CW132
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW032
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® Stabilizer
UDI-DI code: 06419587606057
Basic UDI-DI: B-06419587606057
Reference / catalog number: 606050
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 Stabilizer is an in vitro diagnostic medical device intended to be used in conjunction with GastroPanel Gastrin-17 (Cat. 606035), GastroPanel Pepsinogen I (REF 606010), GastroPanel Pepsinogen II (REF 606020), GastroPanel Helicobacter pylori (REF 606040), Gastrin-17 Advanced (REF 601035), GastroPanel Four-in-One (REF 606080), GastroPanel quick test (REF 602320) and GastroPanel quick test NT (REF 602410) with the corresponding sample type, either EDTA plasma or serum to stabilize measured biomarkers. The product is used manually and is intended to be used by healthcare professionals, either in a laboratory-based or point of care (POC) setting. Package size: 1 x 5.5 ml
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01029099IMMUNOCHEMISTRY 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

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