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Epredia Flex 95

by Richard-Allan Scientific LLC

Epredia Flex 95 (8205) is a reagent grade alcohol solution IVD (FDA Class I; FDA product code PPM, General Purpose Reagent) made by Richard-Allan Scientific LLC, listed in FDA GUDID since 28 Jul 2024 (UDI-DI 00673693179539), 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 Number00673693179539 UDI-DI Date28 Jul 2024ListedStatusListed 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  • Withdrawn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
Epredia
Generic name
Reagent grade alcohol solution IVD
Model / Ref / Catalog
Flex 95, 8205
Primary DI / UDI-DI
00673693179539
FDA product code
PPM
GMDN term
Reagent grade alcohol solution IVD
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Reagent grade alcohol solution IVD

Similar devices

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

Other devices from Richard-Allan Scientific LLC

See all devices from Richard-Allan Scientific LLC →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)