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Immunalysis Corporation FC-219-15

by Alere Inc.

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840937106624 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Immunalysis Corporation
Generic Name
Multiple catecholamine IVD, kit, enzyme immunoassay (EIA)
Model / Reference
FC-219-15
Primary DI / UDI-DI
00840937106624
GMDN Term
Multiple catecholamine IVD, kit, enzyme immunoassay (EIA)
GUDID distribution status
Not in Commercial Distribution

Other devices from Alere Inc.

  • AFP RIA Kit

    Class III

Properties

  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No