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Bio-Rad Laboratories 25183

by Bio-Rad Laboratories

Bio-Rad Laboratories 25183 is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K991975 on 2 Nov 1999 and listed in FDA GUDID since 4 Jan 2023 (UDI-DI 00847865010788), 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) K991975

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 Number00847865010788 UDI-DI Date4 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK991975 Date2 Nov 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K991975 decided 2 Nov 1999 Active
  • FDA GUDID UDI-DI 00847865010788 listed 4 Jan 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K991975
  2. Listed FDA GUDID 00847865010788

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bio-Rad Laboratories
Generic name
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
25183
Primary DI / UDI-DI
00847865010788
510(k) Number
FDA product code
LSE
GMDN term
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class I
Regulation number
866.3235
GUDID distribution status
In Commercial Distribution

Related devices

Category: Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K991975)

Similar devices

Other devices filed under FDA product code LSE (EPSTEIN-BARR VIRUS, OTHER).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

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