86076/12

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.
• CW032

  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.
• CW076

  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 1 country total.

Trade name

not provided

UDI-DI code

08033891329471

Basic UDI-DI

803389132TG00BL

Reference / catalog number

86076/12

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

CHORUS TG is an immunoassay kit for automated quantitative determination of Thyroglobin (TG), performed in human serum, using a disposable device applied on the Chorus and Chorus TRIO instruments. High TG level is reported in various Thyroid diseases like hyperthyroidism, non-toxicgoitre, thyroiditis and differentiated Thyroid carcinoma. The main clinical application for the TG determination, however, is represented by the post-operative monitoring of differentiated thyroid carcinoma. For this reason, the kit is intended to be used as an aid in the relative diagnosis and monitoring. 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.

• W01020408THYROGLOBULIN