PerioPOC Pro

Organization name

GENSPEED Biotech

SRN

AT-MF-000013008

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 1 country total.

Trade name

PerioPOC Pro

UDI-DI code

09120131770052

Basic UDI-DI

B-09120131770052

Reference / catalog number

PPTK002

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

PerioPOCPro is a rapid test for the semi-quantitative detection of five periodontitis-associated bacteria in subgingival sulcusfluid. PerioPOCPro is to be used for near-patient testing by healthcare professionals only at the point of care in combination with the automated GENSPEED R2 Analyzer. PerioPOCPro is not intended to provide the sole diagnostic parameter for periodontitis.

Additional information URL

https://www.genspeed-biotech.com/

Clinical sizes

No clinical sizes registered for this device.

• W0105011699BACTERIOLOGY - NA REAGENTS - OTHER

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Certificate health across this manufacturer's portfolio.