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Autoimmune EIA 240DD

by Bio-Rad Laboratories

Autoimmune EIA 240DD is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K960091 on 20 Mar 1996 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817007033), 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) K960091

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 Number00847817007033 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK960091 Date20 Mar 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K960091 decided 20 Mar 1996 Active
  • FDA GUDID UDI-DI 00847817007033 listed 12 Sep 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1648-2011 FDA Unclassified (pre-2012) initiated 2 Mar 2010
    • Terminated Z-1647-2011 FDA Unclassified (pre-2012) initiated 2 Mar 2010

    The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.

Timeline

4 dated events

  1. Cleared FDA 510(k) K960091
  2. Recall initiated FDA recalls Z-1648-2011
  3. Recall initiated FDA recalls Z-1647-2011
  4. Listed FDA GUDID 00847817007033

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Autoimmune EIA
Generic name
Double stranded DNA antibody (anti-dsDNA) IVD, reagent
Model / Ref / Catalog
240DD
Primary DI / UDI-DI
00847817007033
510(k) Number
FDA product code
LRM
GMDN term
Double stranded DNA antibody (anti-dsDNA) IVD, reagent
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 30 Milliliter

Related devices

Category: Double stranded DNA antibody (anti-dsDNA) IVD, reagent

Cleared under the same submission (K960091)

Similar devices

Other devices filed under FDA product code LRM (ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

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