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Sm IgG ELISA EIA-2784

by DRG International, Inc.

Sm IgG ELISA EIA-2784 is a Class II device made by DRG International, Inc., cleared under FDA 510(k) K941409 on 10 Jun 1994 and listed in FDA GUDID since 23 Aug 2023 (UDI-DI 00840239027849), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K941409

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 Number00840239027849 UDI-DI Date23 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK941409 Date10 Jun 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K941409 decided 10 Jun 1994 Active
  • FDA GUDID UDI-DI 00840239027849 listed 23 Aug 2023 Listed

Recalls

1 recall · FDA

    • Terminated Z-1089-2009 FDA Unclassified (pre-2012) initiated 19 Aug 2008

    The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.

Timeline

3 dated events

  1. Cleared FDA 510(k) K941409
  2. Recall initiated FDA recalls Z-1089-2009
  3. Listed FDA GUDID 00840239027849

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sm IgG ELISA
Generic name
Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
EIA-2784
Primary DI / UDI-DI
00840239027849
510(k) Number
FDA product code
LJM
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 (K941409)

and 7 more cleared under K941409

Similar devices

Other devices filed under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls).

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)