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Phoenix Biotech 525777

by Clark Laboratories, Inc.

Phoenix Biotech 525777 is a Class II device made by Clark Laboratories, Inc., listed in FDA GUDID since 6 Aug 2019 (UDI-DI 05391516746847), 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 Number05391516746847 UDI-DI Date6 Aug 2019ListedStatusListed 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  • Withdrawn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
Phoenix Biotech
Generic name
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
525777
Primary DI / UDI-DI
05391516746847
FDA product code
LIP
GMDN term
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.3830
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 25 Milliliter

Related devices

Category: Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices

Other devices filed under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum).

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)