86074

Organization name

DIESSE Diagnostica Senese S.p.A

SRN

IT-MF-000013311

Manufacturer status

Active

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• CW008

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

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• CW010

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• CW265

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• CW032

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• CW083

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• CW076

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Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

08033891323592

Basic UDI-DI

803389132CHORUSATPO00C7

Reference / catalog number

86074

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 a-TPO is an immunological kit for the quantitative automated determination of class IgG anti-Thyroid Peroxidase (TPO) antibodies. The test is performed on human serum using a disposable device applied on CHORUS/CHORUS TRIO/CHORUS EVO instruments. The kit is intended to detect the presence of IgG class anti-Thyroid Peroxidase (TPO) antibodies as an aid in the diagnosis and monitoring of autoimmune thyroid diseases. Consequently, the target population consists of patients suspected of having an autoimmune thyroid disease. The test is to be used only by professional laboratory personnel properly trained."

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.

• W0102100301THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES