VIRUS vs. BACTERIA

Organization name

Smart Blood Analytics Swiss SA

SRN

CH-MF-000024251

Manufacturer status

Active

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• CW010

  • The VIRUS vs. BACTERIA software can only be used if biological sex, age and all required blood test parameters from the List of blood parameters are available. • All requested laboratory blood tests need to be measured within a maximum of 10 days. • The VIRUS vs. BACTERIA software is not designed to be used on healthy pa-tients or patients without signs or symptoms of viral or bacterial infections. The use of the software on healthy patients will provide non-relevant information. • If the model predicts that a viral infection is more likely, this does not rule out a bacterial infections or vice versa. This prediction should not be used as the sole basis for treatment or patient management decisions.

Primary placement in Slovenia; available across 32 countries total.

Trade name

not provided

UDI-DI code

07649996089328

Basic UDI-DI

7649996089VBWL

Reference / catalog number

VIRUS vs. BACTERIA

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

VIRUS vs. BACTERIA is a clinical decision support software intended for differentiating between viral and bacterial infections. It is based on 17 routine blood test results, biological sex, and age. The device is intended to be used by physicians for patients with symptoms of a viral or bacterial infection.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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