Kallestad 30443

by Bio-Rad Laboratories

Kallestad 30443 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 00847865001694), 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

2 closed

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00847865001694 UDI-DI	Date12 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK813592	Date18 Jan 1982Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00847865001694
FDA 510(k) database 510(k) number K813592

Across registries

2 registries list this device

FDA 510(k) K813592 decided 18 Jan 1982 Active
FDA GUDID UDI-DI 00847865001694 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

18 Jan 1982 Cleared FDA 510(k) K813592
29 Jul 2008 Recall initiated FDA recalls Z-2429-2008
30 Jun 2010 Recall initiated FDA recalls Z-3051-2011
12 Sep 2016 Listed FDA GUDID 00847865001694

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Kallestad
Generic name: Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay
Model / Ref / Catalog: 30443

Primary DI / UDI-DI: 00847865001694
510(k) Number: K813592
FDA product code: DHN
GMDN term: Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay

Device class: Class II
Regulation number: 866.5100
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay.

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Properties

Single use
Convenience kit
Lot / batch number
Expiration date

Other properties (11, all answered No)