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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

732020 — IVDD — General IVDD by Mast Diagnostica GmbH

MD Atlas
Mast Diagnostica GmbH

EUDAMED last updated this device on Apr 26, 2024

732020

B-04250729700224

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Mast Diagnostica GmbH
UDI-DI code: 04250729700224
Reference / catalog number: 732020

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Manufacturer information

Organization name: Mast Diagnostica GmbH
SRN: DE-MF-000005298
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW266
Material of human origin given in IFU.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04250729700224
Basic UDI-DI: B-04250729700224
Reference / catalog number: 732020
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The MASTAZYME™ ds DNA is an enzyme immunoassay for the detection and semi- quantification of specific antibodies against double stranded DNA (dsDNA) in serum and plasma, used in the analysis of autoimmune diseases. The assay is suitable for manual or automated use on open EIA processor systems and is intended for professional in vitro diagnostic use only. All laboratory test results should be interpreted in conjunction with other clinical data. The clinical judgement and further tests have to be taken into account.
Additional information URL: https://www.mast-group.com/de/products/autoimmune-diagnostics/autoimmune-elisa-ana/732020/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102100105DS DNA - ANTIBODIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.