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IFA nDNA Test System FA1001

by Zeus Scientific, Inc.

IFA nDNA Test System FA1001 is a medical device made by Zeus Scientific, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00845533001342), 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 Number00845533001342 UDI-DI Date24 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  • Withdrawn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
IFA nDNA Test System
Generic name
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
Model / reference
FA1001
Primary DI / UDI-DI
00845533001342
GMDN term
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
GUDID distribution status
In Commercial Distribution

Related devices

Category: Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Other devices from Zeus Scientific, Inc.

See all devices from Zeus Scientific, Inc. →

Properties

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