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Platelia 26211

by Bio-Rad

Platelia 26211 is a Class II device made by Bio-Rad, cleared under FDA 510(k) K090847 on 1 Jul 2009 and listed in FDA GUDID since 16 Aug 2016 (UDI-DI 03610520007853), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K090847

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03610520007853 UDI-DI Date16 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK090847 Date1 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090847 decided 1 Jul 2009 Active
  • FDA GUDID UDI-DI 03610520007853 listed 16 Aug 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2515-2025 FDA Class II initiated 30 May 2025

    Due to a risk of false positive results that could lead to unnecessary medical treatment.

Timeline

3 dated events

  1. Cleared FDA 510(k) K090847
  2. Listed FDA GUDID 03610520007853
  3. Recall initiated FDA recalls Z-2515-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Platelia
Generic name
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
26211
Primary DI / UDI-DI
03610520007853
510(k) Number
FDA product code
LGD
GMDN term
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.3780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices

Other devices filed under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii).

Other devices from Bio-Rad

See all devices from Bio-Rad →

Properties

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