FDA.reportPublic FDA data

ASSURE TECH LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30306481603030648160ASSURE TECH LLC1Y2026-01-011521 Concord Pike Suite 201 Wilmington DE US 19803

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3263441209071356K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT2026-06-05
3263441325860895K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT2025-08-15
3263441811149151K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX2025-02-13
3263441386689271K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupNFT2025-02-07
3263441684680754K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamLCX2025-01-15
3263441198980895K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL2024-03-06
3263441870980432K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test MidstreamLCX2024-02-05
3263441187757096K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG2021-08-12
3263441539111534K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-08-20
3263441246528556K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-04-05
3263441558628198K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestNFT2017-05-02
3263442020213801K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)DJC2016-07-06
3263441587191466K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)DKZ2016-03-31
3263441070128456K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripJHI2016-02-24
3263441735667234K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)DJR2015-10-05
3263441677665878K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split CupDIS2015-06-04
3263441026524914
3263441098090792
3263441183623968
3263441196121752
3263441241559085
3263441279452608
3263441279542559
3263441317129310
3263441328171390
3263441352764627
3263441368534396
3263441405489748
3263441412471049
3263441453986560
3263441620133476
3263441634178118
3263441674655347
3263441805685601
3263441879467307
3263441928531840
3263441979331802
3263442009216371
3263442020931456

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NFT52025-08-15
LCX32025-02-13
QYT12026-06-05
NGL12024-03-06
DJG12021-08-12
DJC12016-07-06
DKZ12016-03-31
JHI12016-02-24
DJR12015-10-05
DIS12015-06-04