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Tinto CD16, EP364, RMab

by Bio SB Inc 3 variants

Ref BSB 3323

Tinto CD16, EP364, RMab (BSB 3323) is a device classified as IVD General (EU), Class I (US) made by Bio Sb, Inc., registered in EUDAMED on 6 Dec 2025 (Basic UDI-DI B-B502BSB33230) and listed in FDA GUDID since 1 Jun 2020 (UDI-DI B502BSB33230), active as of 22 Oct 2026.

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

CE IVDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-B502BSB33230 Basic UDI-DI B502BSB33230UDI-DIDate6 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB502BSB33230 UDI-DI Date1 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B502BSB33230 registered 6 Dec 2025 Active
  • FDA GUDID UDI-DI B502BSB33230 listed 1 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B502BSB33230
  2. Registered EUDAMED B-B502BSB33230

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Tinto CD16, EP364, RMab EUDAMED
Tinto CD16, RMab GUDID
Generic name
CD16 cell marker IVD, antibody
Model / Ref / Catalog
BSB 3323, Predilute, 15 ml
Description
Tinto CD16 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
Primary DI / UDI-DI
B502BSB33230
Basic UDI-DI
B-B502BSB33230
FDA product code
NJT
EMDN code
W01030709 Primary antisera for immunohistology
GMDN term
CD16 cell marker IVD, antibody
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
864.1860
EU registration type
Legacy device (under a directive)
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BSB 3323
GUDID
Predilute, 15 ml
Device classEUDAMED
Class IVD General
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
US-MF-000036462
Authorised representative
QAdvis EAR AB SE-AR-000001599

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Properties

  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Premarket exempt
Other properties (22, all answered No)