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Rheumatoid Factor Screen ELISA EIA-3583

by DRG International, Inc.

Rheumatoid Factor Screen ELISA EIA-3583 is a Class II device made by DRG International, Inc., cleared under FDA 510(k) K100499 on 27 Oct 2010 and listed in FDA GUDID since 25 Aug 2023 (UDI-DI 00840239035837), 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) K100499

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 Number00840239035837 UDI-DI Date25 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100499 Date27 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100499 decided 27 Oct 2010 Active
  • FDA GUDID UDI-DI 00840239035837 listed 25 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100499
  2. Listed FDA GUDID 00840239035837

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rheumatoid Factor Screen ELISA
Generic name
Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
EIA-3583
Primary DI / UDI-DI
00840239035837
510(k) Number
FDA product code
DHR
GMDN term
Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.5775
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K100499)

Similar devices

Other devices filed under FDA product code DHR (System, Test, Rheumatoid Factor).

Other devices from DRG International, Inc.

See all devices from DRG International, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)