Skip to content

IgD AMR Fluid BP506

by The Binding Site Group

IgD AMR Fluid BP506 is a Class I device made by The Binding Site Group, listed in FDA GUDID since 7 Jun 2023 (UDI-DI 05051700015974), 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 Number05051700015974 UDI-DI Date7 Jun 2023ListedStatusListed 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  • Withdrawn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
IgD AMR Fluid
Generic name
Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
Model / reference
BP506
Primary DI / UDI-DI
05051700015974
FDA product code
JJX
GMDN term
Total immunoglobulin D (IgD total) IVD, kit, nephelometry/turbidimetry
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).

Other devices from The Binding Site Group

See all devices from The Binding Site Group →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)