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Rickettsia IFA IgG IF0100G

by DiaSorin Molecular LLC

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 Number20816101020243 UDI-DI Date13 Mar 2026ListedStatusListed 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  • Withdrawn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
Rickettsia IFA IgG
Generic Name
Rickettsia conorii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
IF0100G
Primary DI / UDI-DI
20816101020243
510(k) Number
FDA Product Code
GPN
GMDN Term
Rickettsia conorii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Device Class
Class I
Regulation Number
866.3500
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K864110)

Other devices from DiaSorin Molecular LLC

See all devices from DiaSorin Molecular LLC →

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