Skip to content

LetsGetChecked Blood and Urine Sample Collection Kit (ST04) BU09S

by Privapath Diagnostics Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00810111410533 UDI-DI Date7 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LetsGetChecked Blood and Urine Sample Collection Kit (ST04)
Generic Name
General specimen collection kit IVD, home-use
Model / Ref / Catalog
BU09S
Primary DI / UDI-DI
00810111410533
FDA Product Code
OIB
GMDN Term
General specimen collection kit IVD, home-use
Device Class
Class I
Regulation Number
864.3250
GUDID distribution status
In Commercial Distribution

Other devices from Privapath Diagnostics Limited

See all devices from Privapath Diagnostics Limited →

Properties

  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No