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Bactidrop R21507

by Remel, Inc.

Ref R21507

Bactidrop R21507 is a biological stain IVD (EU IVDR Class A; FDA Class I; FDA product code JTS, Stains, Microbiologic) made by Remel, Inc., registered in EUDAMED on 1 Apr 2026 (Basic UDI-DI 8488380BDrpCalcoFWhite5G) and listed in FDA GUDID since 23 Dec 2022 (UDI-DI 00848838023750), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8488380BDrpCalcoFWhite5G Basic UDI-DI 00848838023750UDI-DIDate1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838023750 UDI-DI Date23 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8488380BDrpCalcoFWhite5G registered 1 Apr 2026 Active
  • FDA GUDID UDI-DI 00848838023750 listed 23 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848838023750
  2. Registered EUDAMED 8488380BDrpCalcoFWhite5G

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  • Withdrawn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 Calcofluor White EUDAMED
Bactidrop GUDID
Generic name
Biological stain IVD
Model / Ref / Catalog
R21507
Primary DI / UDI-DI
00848838023750
Basic UDI-DI
8488380BDrpCalcoFWhite5G
FDA product code
JTS
EMDN code
W0104010804 Stains
GMDN term
Biological stain IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.1850
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: Biological stain IVD

Similar devices in this category

Other devices filed under STAINS.

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)