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Access Hybritech free PSA (Reagent Pack)

by Beckman Coulter Inc.

Ref 37210

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number150995901AccHfPSAMQ Basic UDI-DI 15099590232344UDI-DIDate3 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590232344 UDI-DI Date16 Sep 2014ListedStatusListed 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  • Withdrawn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
Access Hybritech free PSA (Reagent Pack) EUDAMED
Access Hybritech free PSA GUDID
Generic Name
Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
37210
Primary DI / UDI-DI
15099590232344 EUDAMED
H628372101 GUDID
Basic UDI-DI
150995901AccHfPSAMQ
FDA Product Code
MTG
EMDN Code
W0102030114 Free prostatic specific antigen
GMDN Term
Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Device Class
Class C EUDAMED
Class III GUDID
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
15099590232344
GUDID
H628372101
Device ClassEUDAMED
Class C
GUDID
Class III

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

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Properties

  • Single Use
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No