86900

Organization name

DIESSE Diagnostica Senese S.p.A

SRN

IT-MF-000013311

Manufacturer status

Active

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

• CW008

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW265

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW083

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 2 countries total.

Trade name

not provided

UDI-DI code

08033891329709

Basic UDI-DI

803389132VITAMIND00GP

Reference / catalog number

86900

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

CHORUS 25 OH VITAMIN D TOTAL is an immunoassay kit for automated quantitative detection of 25 (OH) Vitamin D, performed in human serum using a disposable device applied on the Chorus and Chorus TRIO instruments. Since 25 (OH)Vitamin D is considered the main form of storage of Vitamin D, the kit is intended to monitor the overall Vitamin D status and the relative therapeutic measures. It must be used by professional laboratory users only.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• W010206030925-HYDROXYVITAMIN D