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Kallestad 32514

by Bio-Rad Laboratories

Kallestad 32514 is a Class II device made by Bio-Rad Laboratories, listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847865001496), 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 Number00847865001496 UDI-DI Date12 Sep 2016ListedStatusListed 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  • Withdrawn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
Kallestad
Generic name
Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
32514
Primary DI / UDI-DI
00847865001496
FDA product code
LHL
GMDN term
Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.3300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Similar devices

Other devices filed under FDA product code LHL (REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)