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Bionova® BT20

by Terragene S.A. 3 variants

Bionova® BT20 is a Class II device made by Terragene S.A., listed in FDA GUDID since 16 Oct 2025 (UDI-DI 07798164673545), 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 Number07798164673545 UDI-DI Date16 Oct 2025ListedStatusListed 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  • Withdrawn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
Bionova®
Generic name
Biological sterilization indicator
Model / reference
BT20
Primary DI / UDI-DI
07798164673545
FDA product code
FRC
GMDN term
Biological sterilization indicator
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FRC (Indicator, Biological Sterilization Process).

Other devices from Terragene S.A.

See all devices from Terragene S.A. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)