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Cytokeratin 19 +1 more model

EUDAMED

Class C (EU MDR)

Ref A00122-0007Ref A00122-0025

by ScyTek Laboratories Inc.

Identity

Trade Name
Cytokeratin 19; Clone A53-B/A2.26 (Ready-To-Use) 7 mL EUDAMED
Cytokeratin 19; Clone A53-B/A2.26 (Ready-To-Use) 25 mL EUDAMED
Device Name
Primary Antisera for Immunohistology EUDAMED
Model / Reference
A00122-0007 EUDAMED
A00122-0025 EUDAMED

Identifiers

Primary DI / UDI-DI
00810108711728 EUDAMED
00810108711735 EUDAMED
Basic UDI-DI
081010871W01030709FJ EUDAMED
Direct Marketing DI
00810108711728 EUDAMED
00810108711735 EUDAMED
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
Models / Variants
Cytokeratin 19 EUDAMED
Clone A53-B/A2.26 (Ready-To-Use) 7 mL EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Cytokeratin 19 +1 more model by ScyTek Laboratories Inc. — Class C — IVDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS

Manufacturer's product page: Hairy Cell Leukemia; Clone DBA.44 (Ready-To-Use) SKU: A00015 Antibodies, Monoclonal

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
ScyTek Laboratories Inc.
EUDAMED SRN
US-MF-000023816
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED a3eb02fe-a0c7-4046-af7f-20fd236234e7 61 fields · synced Jul 15, 2026
  • EUDAMED 9c9a4118-92a7-48df-8e87-bae75adb1e77 61 fields · synced May 18, 2026