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ISE Buffer (IS) 781611334

by Jeol

ISE Buffer (IS) 781611334 is a Class I device made by Jeol, listed in FDA GUDID since 9 Oct 2020 (UDI-DI 04987762129759), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987762129759 UDI-DI Date9 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ISE Buffer (IS)
Generic name
Multiple clinical chemistry enzyme IVD, control
Model / reference
781611334
Primary DI / UDI-DI
04987762129759
FDA product code
PPM
GMDN term
Multiple clinical chemistry enzyme IVD, control
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple clinical chemistry enzyme IVD, control

Similar devices

Other devices filed under FDA product code PPM (General Purpose Reagent).

Other devices from Jeol

See all devices from Jeol →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)