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BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application 444908

by BD Kiestra B.V.

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 Number00382904449087 UDI-DI Date17 Dec 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  • Withdrawn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
BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
Generic Name
Histology/cytology/microbiology image-analysis interpretive software IVD
Model / Ref / Catalog
444908
Primary DI / UDI-DI
00382904449087
510(k) Number
FDA Product Code
QQY
GMDN Term
Histology/cytology/microbiology image-analysis interpretive software IVD
Device Class
Class II
Regulation Number
866.2190
GUDID distribution status
In Commercial Distribution

Other devices from BD Kiestra B.V.

See all devices from BD Kiestra B.V. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (11)

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