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NOVEOS Crab, Callinectes spp. F023

by Hycor Biomedical LLC 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816879024999 UDI-DI Date1 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
NOVEOS Crab, Callinectes spp.
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Model / Ref / Catalog
F023, 8632340
Primary DI / UDI-DI
00816879024999
510(k) Number
FDA Product Code
DHB, JJE
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Device Class
Class II
Regulation Number
866.5750, 862.2160
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K260280)

Show all (9)

Other devices from Hycor Biomedical LLC

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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