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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

Cytokeratin 5/14 (QR027 & QR057) — IVDD — General IVDD

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

EUDAMED last updated this device on Oct 9, 2023

Cytokeratin 5/14 (QR027 & QR057)

B-C-C035-05ZF

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: biocyc Biotechnologie GmbH & Co. KG
UDI-DI code: D-C-C035-05ZF
Reference / catalog number: C-C035-05

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Manufacturer information

Organization name: biocyc Biotechnologie GmbH & Co. KG
SRN: DE-MF-000031533
Manufacturer status: Active

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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: Cytokeratin 5/14 (QR027 & QR057)
UDI-DI code: D-C-C035-05ZF
Basic UDI-DI: B-C-C035-05ZF
Reference / catalog number: C-C035-05
Issuing entity: EUDAMED

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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030709PRIMARY ANTISERA FOR IMMUNOHISTOLOGY

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

HX 1108389-1Issued
Quality management systemNotified body: 0197Expiry: Jun 20, 2029