FDA.reportPublic FDA data

AZURE BIOTECH INC

Matched from indexed company URL: Azure Biotech, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30148623513014862351AZURE BIOTECH INC1Y2026-01-0110400 Main Street Houston TX US 77025

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2226541526383257K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-08-20
2226541447040293K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT2018-04-05
2226541856805320K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestNFT2017-05-02
2226541610260789K161044AssureTech 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
2226541832064470K153465AssureTech 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
2226541812608086K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripJHI2016-02-24
2226542042985129K152025AssureTech 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
2226541475634632K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split CupDIS2015-06-04
2226541388206309K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTERLCX2013-03-14
2226542048157124K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSJHI2012-07-17
2226541416410665
2226541996895682
2226541288892058
2226541855610541

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NFT32018-08-20
JHI22016-02-24
DJC12016-07-06
DKZ12016-03-31
DJR12015-10-05
DIS12015-06-04
LCX12013-03-14

GUDID#