81062

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.
• CW032

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

  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

08033891322403

Basic UDI-DI

803389132CHORUSPYA00C7

Reference / catalog number

81062

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 HELICOBACTER PYLORI IgA (REF 81062) is an immunoassay kit for the automated qualitative determination of IgA antibodies against Helicobacter pylori. Helicobacter pylori infection causes a systemic (IgM, IgG) and local (IgA) immune response; therefore, the kit is used as an aid in the diagnosis of Helicobacter pylori infection. The test, performed in human serum using a disposable device applied to the CHORUS and CHORUS TRIO instruments, must be used by professional laboratory personnel only. The device is For In Vitro Diagnostic Use 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.

• W0105010402H. PYLORI ANTIBODY ASSAYS