Skip to content

Secondary Antisera

by ScyTek Laboratories Inc. 52 variants

Ref PAM008

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Overview

The Secondary Antisera device is a medical device designed to provide accurate and reliable results for secondary antisera testing. This device features a sterile environment, standard compliance, and a companion diagnostics score of zero. The device's status type ID indicates that it is not an implantable device, human tissue is not applicable, and the status ID shows that it has been listed on the market for -162 days.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081010871W01030710F3 Basic UDI-DI 00810108717010UDI-DIDate7 Dec 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
PAM008
Primary DI / UDI-DI
00810108717010
Basic UDI-DI
081010871W01030710F3
Direct Marketing DI
00810108717010
EMDN Code
W01030710 Secondary antisera for immunohistology
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000023816
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from ScyTek Laboratories Inc.

See all devices from ScyTek Laboratories Inc. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No