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SAS StrepAlert 611530

by SA Scientific, Ltd

SAS StrepAlert 611530 is a medical device made by SA Scientific, Ltd, listed in FDA GUDID since 1 Nov 2018 (UDI-DI 00780311000448), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00780311000448 UDI-DI Date1 Nov 2018ListedStatusListed 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  • Withdrawn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
SAS StrepAlert
Generic name
Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Model / reference
611530
Primary DI / UDI-DI
00780311000448
GMDN term
Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
GUDID distribution status
In Commercial Distribution

Related devices

Category: Streptococcus pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Other devices from SA Scientific, Ltd

See all devices from SA Scientific, Ltd →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Serial number
Other properties (11, all answered No)