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Q Fever IFA IgM IF0200M

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 Number20816101020359 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  • Withdrawn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
Q Fever IFA IgM
Generic Name
Coxiella burnetii nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
IF0200M
Primary DI / UDI-DI
20816101020359
510(k) Number
FDA Product Code
GPJ
GMDN Term
Coxiella burnetii nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Class
Class I
Regulation Number
866.3500
GUDID distribution status
In Commercial Distribution

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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