Skip to content

Remel R01061

by Remel, Inc.

Remel R01061 is a Class I device made by Remel, Inc., listed in FDA GUDID since 22 Dec 2022 (UDI-DI 00848838000195), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00848838000195 UDI-DI Date22 Dec 2022ListedStatusListed GUDID: not 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  • Withdrawn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
Remel
Generic name
Anaerobic-microorganism antimicrobial susceptibility culture medium IVD
Model / Ref / Catalog
R01061
Primary DI / UDI-DI
00848838000195
FDA product code
JSH
GMDN term
Anaerobic-microorganism antimicrobial susceptibility culture medium IVD
Device class
Class I
Regulation number
866.2320
GUDID distribution status
Not in Commercial Distribution

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

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