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R. STR Test(L) 48 5848RL

by Scimedx Corp.

R. STR Test(L) 48 5848RL is a Class II device made by Scimedx Corp., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00813545023034), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813545023034 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
R. STR Test(L) 48
Generic name
Striated muscle antibody IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
5848RL
Primary DI / UDI-DI
00813545023034
FDA product code
DBL
GMDN term
Striated muscle antibody IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.5660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Striated muscle antibody IVD, kit, fluorescent immunoassay

Similar devices

Other devices filed under FDA product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control).

Other devices from Scimedx Corp.

See all devices from Scimedx Corp. →

Properties

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