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Scl-70 IgG ELISA EIA-2786

by DRG Instruments Gesellschaft mit beschränkter Haftung

Scl-70 IgG ELISA EIA-2786 is a Class II device made by DRG Instruments Gesellschaft mit beschränkter Haftung, cleared under FDA 510(k) K941409 on 10 Jun 1994 and listed in FDA GUDID since 29 Aug 2023 (UDI-DI 04048474027860), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048474027860 UDI-DI Date29 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 04048474027860 listed 29 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 04048474027860

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Scl-70 IgG ELISA
Generic name
Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
EIA-2786
Primary DI / UDI-DI
04048474027860
510(k) Number
FDA product code
LJM
GMDN term
Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Scleroderma-70 antibody (anti-Scl-70) 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 Instruments Gesellschaft mit beschränkter Haftung

See all devices from DRG Instruments Gesellschaft mit beschränkter Haftung →

Properties

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