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Kallestad 26115

by Bio-Rad Laboratories

Kallestad 26115 is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K813592 on 18 Jan 1982 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847865001724), active as of 23 Oct 2026. 2 FDA recalls are 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

None ongoing

2 closed

Documents

510(k) K813592

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847865001724 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK813592 Date18 Jan 1982DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K813592 decided 18 Jan 1982 Active
  • FDA GUDID UDI-DI 00847865001724 listed 12 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-3051-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2010

    KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.

    • Terminated Z-2429-2008 FDA Unclassified (pre-2012) initiated 29 Jul 2008

    The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.

Timeline

4 dated events

  1. Cleared FDA 510(k) K813592
  2. Recall initiated FDA recalls Z-2429-2008
  3. Recall initiated FDA recalls Z-3051-2011
  4. Listed FDA GUDID 00847865001724

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kallestad
Generic name
Multiple antinuclear antibody (ANA) IVD, reagent
Model / Ref / Catalog
26115
Primary DI / UDI-DI
00847865001724
510(k) Number
FDA product code
DHN
GMDN term
Multiple antinuclear antibody (ANA) IVD, reagent
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple antinuclear antibody (ANA) screening IVD, reagent

Cleared under the same submission (K813592)

Similar devices

Other devices filed under FDA product code DHN (ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)