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Immunalysis GPR-E-188-40

by Immunalysis Corporation

Immunalysis GPR-E-188-40 is a Class I device made by Immunalysis Corporation, listed in FDA GUDID since 25 May 2017 (UDI-DI 00840937110164), 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 Number00840937110164 UDI-DI Date25 May 2017ListedStatusListed 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  • Withdrawn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
Immunalysis
Generic name
Immunohistochemistry antibody diluent IVD
Model / Ref / Catalog
GPR-E-188-40
Primary DI / UDI-DI
00840937110164
FDA product code
PPM
GMDN term
Immunohistochemistry antibody diluent IVD
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code PPM (General Purpose Reagent).

Other devices from Immunalysis Corporation

See all devices from Immunalysis Corporation →

Properties

  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)