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Histamine ELISA EIA-5827

by DRG International, Inc.

Histamine ELISA EIA-5827 is a multiple biogenic amine neurotransmitter IVD (FDA Class I; FDA product code IAF, Wright'S Stain) made by DRG International, Inc., listed in FDA GUDID since 26 Aug 2023 (UDI-DI 00840239058270), 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 Number00840239058270 UDI-DI Date26 Aug 2023ListedStatusListed 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  • Withdrawn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
Histamine ELISA
Generic name
Multiple biogenic amine neurotransmitter IVD, reagent
Model / Ref / Catalog
EIA-5827
Primary DI / UDI-DI
00840239058270
FDA product code
IAF
GMDN term
Multiple biogenic amine neurotransmitter IVD, reagent
Device class
Class I
Regulation number
864.1850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple biogenic amine neurotransmitter IVD, reagent

Similar devices

Other devices filed under FDA product code IAF (Wright'S Stain).

Other devices from DRG International, Inc.

See all devices from DRG International, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)