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Bactidrop R21514

by Remel, Inc.

Ref R21514

Bactidrop R21514 is a device classified as Class A in the EU and Class I in the US made by Remel, Inc., registered in EUDAMED on 1 Apr 2026 (Basic UDI-DI 8488380BDrpFeChlorideXU) and listed in FDA GUDID since 23 Dec 2022 (UDI-DI 00848838023781), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8488380BDrpFeChlorideXU Basic UDI-DI 00848838023781UDI-DIDate1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838023781 UDI-DI Date23 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8488380BDrpFeChlorideXU registered 1 Apr 2026 Active
  • FDA GUDID UDI-DI 00848838023781 listed 23 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848838023781
  2. Registered EUDAMED 8488380BDrpFeChlorideXU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Bactidrop Ferric Chloride (10%) EUDAMED
Bactidrop GUDID
Generic name
Bacterial species differentiation disc IVD
Device name
Bactidrop Ferric Chloride
Model / Ref / Catalog
R21514
Primary DI / UDI-DI
00848838023781
Basic UDI-DI
8488380BDrpFeChlorideXU
FDA product code
JTO
EMDN code
W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
GMDN term
Bacterial species differentiation disc IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
866.2660
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bacterial species differentiation disc IVD

Similar devices

Also classified as Bacterial species differentiation disc IVD.

Similar devices in this category

Other devices filed under BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC).

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)