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PAP-8E Software CD 107153

by Bio/Data Corporation

PAP-8E Software CD 107153 (107053) is a Class II device made by Bio/Data Corporation, listed in FDA GUDID since 30 Aug 2023 (UDI-DI G0561071530), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG0561071530 UDI-DI Date30 Aug 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
PAP-8E Software CD
Generic name
Platelet aggregation analyser IVD
Model / Ref / Catalog
107153, 107053
Primary DI / UDI-DI
G0561071530
FDA product code
JPA
GMDN term
Platelet aggregation analyser IVD
Device class
Class II
Regulation number
864.5425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Platelet aggregation analyser IVD

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Other devices filed under Platelet aggregation analyser IVD.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)