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Autoimmune EIA 96EP

by Bio-Rad Laboratories

Autoimmune EIA 96EP is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K952253 on 24 Aug 1995 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817022388), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K952253

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 Number00847817022388 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK952253 Date24 Aug 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K952253 decided 24 Aug 1995 Active
  • FDA GUDID UDI-DI 00847817022388 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K952253
  2. Listed FDA GUDID 00847817022388

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  • Withdrawn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
Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
96EP
Primary DI / UDI-DI
00847817022388
510(k) Number
FDA product code
LLL
GMDN term
Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K952253)

Similar devices

Other devices filed under FDA product code LLL (EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)