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Novocastra Streptavidin-HRP

by Leica Biosystems Newcastle Ltd

Ref RE7104

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number50553313STRHRP00004PG Basic UDI-DI 05055331302106UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055331302106 UDI-DI Date17 May 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Novocastra Streptavidin-HRP EUDAMED
Novocastra™ GUDID
Generic Name
Streptavidin-enzyme conjugate reagent IVD
Model / Ref / Catalog
RE7104, RE7104-CE
Primary DI / UDI-DI
05055331302106
Basic UDI-DI
50553313STRHRP00004PG
Direct Marketing DI
05055331302106
FDA Product Code
NJT
EMDN Code
W01030799 Histology / cytology reagents - other
GMDN Term
Streptavidin-enzyme conjugate reagent IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RE7104
GUDID
RE7104-CE
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000020595
Authorised representative
AR Experts B.V. NL-AR-000023989

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No