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PremierPro 6913

by Prestige Ameritech

PremierPro 6913 is a Class II device made by Prestige Ameritech, listed in FDA GUDID since 1 Aug 2016 (UDI-DI 00818566016355), 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 Number00818566016355 UDI-DI Date1 Aug 2016ListedStatusListed 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  • Withdrawn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
PremierPro
Generic name
Faecal occult blood IVD, kit, rapid colorimetric, clinical
Model / reference
6913
Primary DI / UDI-DI
00818566016355
FDA product code
KHE
GMDN term
Faecal occult blood IVD, kit, rapid colorimetric, clinical
Device class
Class II
Regulation number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal occult blood IVD, kit, rapid colorimetric, clinical

Similar devices

Other devices filed under FDA product code KHE (Reagent, Occult Blood).

Other devices from Prestige Ameritech

See all devices from Prestige Ameritech →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)