Lyfstone Calprotectin for Synovial Fluid

Organization name

Calpro AS

SRN

NO-MF-000036194

Manufacturer status

Active

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

• CW010

  Read the Instructions for Use carefully before performing the test.
• CW132

  EUDAMED did not publish a description for this code.
• CW007

  Inspect the pouch for holes/leakages prior to use

Primary placement in Norway; available across 14 countries total.

Trade name

Lyfstone Calprotectin for Synovial Fluid

UDI-DI code

07090028590013

Basic UDI-DI

B-07090028590013

Reference / catalog number

LYFCLP001

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Lyfstone® Calprotectin for Synovial Fluid test is a method for risk strat- ification of infection in suspected periprosthetic joint infection (PJI) patients by determination of the calprotectin (CLP) level in human synovial fluid samples in combination with the dedicated Lyfstone® smartphone application. The test is intended as a diagnostic aid for screening of suspected PJI patients in a patient near setting or a laboratory. The test is for professional use only.

Additional information URL

https://lyfstone.com/instructions-for-use/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01010699CLIN. CHEM. RT & POC - OTHER