Myositis Profile 12 Ag OJ Dot for BDI

Organization name

D-tek s.a.

SRN

BE-MF-000024530

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Belgium; available across 18 countries total.

Trade name

Myositis Profile 12 Ag OJ Dot for BDI

UDI-DI code

05425023681770

Basic UDI-DI

B-05425023681770

Reference / catalog number

AD MYOSO12ADBD

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

BlueDiver Dot Myositis IgG kits are immunodot kits allowing the detection, in human serum, of specific IgG auto-antibodies in the context of an auto-immune myositis diagnostic. BlueDiver Dot Myositis IgG kits are intended to be used as confirmatory tests following indirect immunofluorescence assay (IFA), screening and reference method for auto-antibodies detection. The tests are intended for a large, routine population. The kits are strictly reserved for professional use, by trained staff. The kits must be processed on the BlueDiver Instrument.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100108JO-1

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• Expiration date
• Manufacturing date
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