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Peroxidazed 1 PX968H

by Biocare Medical, LLC

Ref PX968HModel Peroxidase Blocking Reagents

Peroxidazed 1 PX968H is a device classified as Class A in the EU and Class I in the US made by Biocare Medical, LLC, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 08476270BPERBLKRZ9) and listed in FDA GUDID since 23 Sep 2022 (UDI-DI 00847627012388), active as of 23 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08476270BPERBLKRZ9 Basic UDI-DI 00847627012388UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847627012388 UDI-DI Date23 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08476270BPERBLKRZ9 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00847627012388 listed 23 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847627012388
  2. Registered EUDAMED 08476270BPERBLKRZ9

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  • Withdrawn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
Peroxidazed 1
Generic name
Immunohistochemistry endogenous enzyme blocking reagent IVD
Model / reference
PX968H, Peroxidase Blocking Reagents
Primary DI / UDI-DI
00847627012388
Basic UDI-DI
08476270BPERBLKRZ9
FDA product code
PPM
EMDN code
W01029099 Immunochemistry reagents - other
GMDN term
Immunohistochemistry endogenous enzyme blocking reagent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Immunohistochemistry endogenous enzyme blocking reagent IVD

Similar devices in this category

Other devices filed under IMMUNOCHEMISTRY REAGENTS - OTHER.

Other devices from Biocare Medical, LLC

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Properties

  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)