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Rapid Capture System

by QIAGEN Sciences LLC

Ref 6000-3101

Rapid Capture System (6000-3101) is a device classified as Class A in the EU and Class I in the US made by QIAGEN Sciences LLC, registered in EUDAMED on 5 May 2026 (Basic UDI-DI 4053228IHPVRCS000000001K8) and listed in FDA GUDID since 15 Aug 2017 (UDI-DI 04053228010821), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4053228IHPVRCS000000001K8 Basic UDI-DI 04053228010821UDI-DIDate5 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04053228010821 UDI-DI Date15 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4053228IHPVRCS000000001K8 registered 5 May 2026 Active
  • FDA GUDID UDI-DI 04053228010821 listed 15 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04053228010821
  2. Registered EUDAMED 4053228IHPVRCS000000001K8

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  • Withdrawn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

Generic name
Specimen processing instrument IVD
Model / Ref / Catalog
6000-3101, 1
Primary DI / UDI-DI
04053228010821
Basic UDI-DI
4053228IHPVRCS000000001K8
Direct marketing DI
04053228010821
FDA product code
JQW
EMDN code
W02050101 Nucleic acid hybridization units
GMDN term
Specimen processing instrument IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2750
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6000-3101
GUDID
1
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.

Manufacturer details

EUDAMED SRN
US-MF-000014502
Authorised representative
QIAGEN GmbH DE-AR-000004971

Similar devices in this category

Other devices filed under NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS.

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Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)