81020

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

08033891322212

Basic UDI-DI

803389132CHORUSHSG0093

Reference / catalog number

81020

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 HERPES SIMPLEX 1+2 IgG is an immunoassay kit for the automated qualitative determination of IgG class antibodies against Herpes simplex virus 1+2. The test, performed in human serum, using a disposable device applied on the CHORUS and CHORUS TRIO instruments. The kit is intended to detect the exposure to Herpes simplex virus (Type 1 and Type 2) infection as an aid to the related diagnosis. 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.

• W0105040303HSV 1+2 IGG