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PSAP (Prostate Specific Acid Phosphatase) +1 more model

EUDAMED

Class C (EU MDR)

Ref A00041-0025Ref A00041-0007

by ScyTek Laboratories Inc.

Identity

Trade Name
PSAP (Prostate Specific Acid Phosphatase); Clone PASE/4LJ (Ready-To-Use) 25 mL EUDAMED
PSAP (Prostate Specific Acid Phosphatase); Clone PASE/4LJ (Ready-To-Use) 7 mL EUDAMED
Device Name
Primary Antisera for Immunohistology EUDAMED
Model / Reference
A00041-0025 EUDAMED
A00041-0007 EUDAMED

Identifiers

Primary DI / UDI-DI
00810108710523 EUDAMED
00810108710516 EUDAMED
Basic UDI-DI
081010871W01030709FJ EUDAMED
Direct Marketing DI
00810108710523 EUDAMED
00810108710516 EUDAMED
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
Models / Variants
PSAP (Prostate Specific Acid Phosphatase) EUDAMED
Clone PASE/4LJ (Ready-To-Use) 25 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

PSAP (Prostate Specific Acid Phosphatase) +1 more model by ScyTek Laboratories Inc. — Class C — IVDR — listed in EUDAMED — 2 models

Manufacturer's product page: Actin, Muscle Specific; Clone HHF35 SKU: A00001 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 e0a5c72b-2838-4f02-a8b8-f3530812642a 61 fields · synced Jul 17, 2026
  • EUDAMED f26cf19e-7e90-4f77-8091-96f9a2d18849 61 fields · synced May 18, 2026