FDA.reportPublic FDA data

Chembio Diagnostic Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30265658543026565854Chembio Diagnostic Systems1N2026-01-011560 Fifth Avenue Bay Shore NY US 11706

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3140321223729752K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeDCK2022-11-04
3140321775969049K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderQFO2020-06-03
3140321520495084DEN220023Procise ADLQYD2023-09-29
3140321874491930DEN210056Procise IFXQXT2023-09-29
3140321612122346BP180191
3140322071783988BP120032
3140321644858497BP050010
3140321935880440BP050009
3140321164800073
3140321196863456
3140321203501902
3140321355693512
3140321417634285
3140321430810002
3140321453912107
3140321508808725
3140321556428107
3140321595865827
3140321599258548
3140321809922621

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QYD12023-09-29
QXT12023-09-29
DCK12022-11-04
QFO12020-06-03

PMN#