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SeraQuest ENA Screen

by Quest International, Inc.

SeraQuest ENA Screen (01-330) is a Class II device made by Quest International, Inc., listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00850487007630), 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 Number00850487007630 UDI-DI Date31 Aug 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  • Withdrawn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
SeraQuest
Generic name
Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
ENA Screen, 01-330
Primary DI / UDI-DI
00850487007630
FDA product code
LLL
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)

Similar devices

Other devices filed under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control).

Other devices from Quest International, Inc.

See all devices from Quest International, Inc. →

Properties

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