FDA.reportPublic FDA data

Confirm Biosciences LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30060484513006048451Confirm Biosciences LLC1Y2026-01-018866 Cypress Court Building E SAN DIEGO CA US 92154

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
256621446152063K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardNGL2024-04-12
256622053507184K191841Accurate Multi Panel Drug Urine Test CupNFT2019-08-07
256621745719089K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM2017-08-02
256621865492713K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2016-05-23
256621307112426K103574PREGNANCY ONE STEP RAPID TESTLCX2011-07-28
256621775797621DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestSCA2024-10-07
256621075410538
256621177352521
256621209345549
256621252132507
256621616208211
256621767182000

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXM22017-08-02
SCA12024-10-07
NGL12024-04-12
NFT12019-08-07
LCX12011-07-28