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Organization name
UDI-DI code
Reference / catalog number

BIOHIT Calprotectin — IVDD — General IVDD by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Sep 27, 2024

BIOHIT Calprotectin

B-06419587022604

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587022604
Reference / catalog number: 602260

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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: BIOHIT Calprotectin
UDI-DI code: 06419587022604
Basic UDI-DI: B-06419587022604
Reference / catalog number: 602260
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: BIOHIT Calprotectin test is a quantitative in vitro enzyme-linked immunosorbent assay (ELISA) aiding in diagnosis of organic disease of the small or large intestine or the stomach such as inflammatory bowel disease, ulcerative colitis or Crohn’s disease by detecting calprotectin in stool samples. In addition, the test is used to monitor the disease activity and the response to treatment in patients with ulcerative colitis or Crohn’s disease. The test can be conducted either manually or automatically and is intended to be used by healthcare professionals only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102019009CALPROTECTIN

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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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.