PST80100EP08

Organization name

Immundiagnostik AG

SRN

DE-MF-000020905

Manufacturer status

Active

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

• CW018

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04050598009103

Basic UDI-DI

B-04050598009103

Reference / catalog number

PST80100EP08

Issuing entity

GS1

Risk category

IVDD — Self-testing

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Preventis SmarTest® Vitamin D Home is a rapid test for the quantitative immunological determination of 25(OH)-vitamin D in capillary blood. This value allows monitoring of the vitamin D status and detection of a possible insufficiency or excess. The manual test system consists of an antibody-based strip test, a so-called lateral flow test, including a smartphone app developed for test evaluation. The test is an in vitro diagnostic device and suitable for self-testing by laypersons 18 years of age and older. The package contains materials to perform one, single-use test.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W010206030925-HYDROXYVITAMIN D

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