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Sofia 20352

by Quidel Cardiovascular Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number30014613338772 UDI-DI Date18 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sofia
Generic Name
Multiple Campylobacter species antibody IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
20352
Primary DI / UDI-DI
30014613338772
510(k) Number
FDA Product Code
LQP
GMDN Term
Multiple Campylobacter species antibody IVD, kit, fluorescent immunoassay
Device Class
Class I
Regulation Number
866.3110
GUDID distribution status
In Commercial Distribution

Other devices from Quidel Cardiovascular Inc.

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Properties

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

Other properties (10)

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