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AGG/PAK 5 Combo Kit 107650

by Bio/Data Corporation

Ref 107650

AGG/PAK 5 Combo Kit 107650 is a device classified as Class A in the EU and Class II in the US made by Bio/Data Corporation, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI ++G05610765056), cleared under FDA 510(k) K790769 on 3 May 1979 and listed in FDA GUDID since 1 Oct 2024 (UDI-DI *+G0561076501/$$1126414000XXX*), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K790769

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++G05610765056 Basic UDI-DI *+G0561076501/$$1126414000XXX*UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number*+G0561076501/$$1126414000XXX* UDI-DI Date1 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK790769 Date3 May 1979DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++G05610765056 registered 16 Jun 2026 Active
  • FDA 510(k) K790769 decided 3 May 1979 Active
  • FDA GUDID UDI-DI *+G0561076501/$$1126414000XXX* listed 1 Oct 2024 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K790769
  2. Listed FDA GUDID *+G0561076501/$$1126414000XXX*
  3. Registered EUDAMED ++G05610765056

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
AGG/PAK™ 5 Combo Kit EUDAMED
AGG/PAK 5 Combo Kit GUDID
Generic name
Platelet aggregation study IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
107650
Primary DI / UDI-DI
*+G0561076501/$$1126414000XXX* EUDAMED
G0561076501 GUDID
Basic UDI-DI
++G05610765056
510(k) Number
FDA product code
JOZ
EMDN code
W01030199 Haematology reagents - other
GMDN term
Platelet aggregation study IVD, kit, nephelometry/turbidimetry
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5700
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
*+G0561076501/$$1126414000XXX*
GUDID
G0561076501
Device classEUDAMED
Class A
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists *+G0561076501/$$1126414000XXX*; FDA GUDID lists G0561076501), so their flags are not compared. Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

From the manufacturer

Manufacturer's product page: Aggregation Combo Kits

Related devices

Category: Platelet aggregation study IVD, kit, nephelometry/turbidimetry

Cleared under the same submission (K790769)

Similar devices in this category

Other devices filed under HAEMATOLOGY REAGENTS - OTHER.

Other devices from Bio/Data Corporation

See all devices from Bio/Data Corporation →

Properties

  • Single use
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Combination product
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)