FDA.reportPublic FDA data

LUMIQUICK DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059840813005984081LUMIQUICK DIAGNOSTICS, INC.1Y2026-01-012946 SCOTT BLVD. SANTA CLARA CA US 95054

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00855636003808QuickProfile™ Covid-19/FluA&B Antigen Combo Test - The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, influenza A and influenza B proteins using self-collected anterior nares nasal swab samples from individuals aged 14 years or older. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset.4088550061info@lumiquick.com
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 Test - Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY / THC1-408-855-0061udi@lumiquick.com
M90107RD7205030QuickProfile™ Drugs of Abuse Test Cup - Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / OPI / THC1-408-855-0061udi@lumiquick.com
M90107RD7205040QuickProfile™ Drugs of Abuse Test Cup - Immunoassay for the detection of the following drug substance(s) in human urine: AMP/ COC / M-AMP / OPI-2000 / THC1-408-855-0061udi@lumiquick.com
M90107RD7205060QuickProfile™ Drugs of Abuse Test Cup - Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / MTD / OPI / OXY1-408-855-0061udi@lumiquick.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
674321747962925K992528BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21
674321565204925K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24
674321180540396K992138MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIESETA1999-08-09
674321267203522K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22
674321737755052K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02
674321255320890K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02
674321331282778K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22
674321150922977K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22
674321554034893K981770RAPIDHCG PREGNANCY TESTJHI1998-06-05
674321767415462K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardNGL2024-05-22
674321548504275K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50LDJ2024-01-17
674321686985487K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test MidstreamLCX2022-04-05
674321849426433K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT2020-09-25
674321038865031K182701Wondfo T-Cup Multi-Drug Urine Test CupNFT2018-12-03
674321785343891K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupDIO2017-06-02
674321297123996K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardDJG2016-04-26
674321975810765K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELDJ2013-10-18
674321074207942K051958MP RAPIDOXY TEST STRIP, MODEL 07RD-7073DJG2006-07-21
674321780189179K043443ONE STEP HCG URINE PREGNANCY TESTLCX2005-04-08
674321276798702K033566MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062DKZ2004-05-17
674321072163794K030211RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016DKX2003-06-13
674321347036722K023252RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020DJR2002-11-22
674321840479733K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117DRR2002-12-19
674321926998166K020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)DJG2002-05-06
674321533162795K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITMMI2002-01-08
674321110053623K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119DCK2001-07-20
674321356080722K003809RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELSDKZ2001-04-20
674322068862112K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115CDZ2000-10-02
674321022214451
674321060540076
674321092293971
674321151976971
674321205987328
674321217596959
674321224137730
674321275650386
674321305117967
674321333685483
674321367596459
674321368061743
674321381529542
674321478617122
674321552496169
674321597707296
674321622281921
674321656511880
674321684678704
674321698874333
674321700955742
674321864374460
674321903154563
674321988974255
674322006971269

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG32016-04-26
LDJ22024-01-17
LCX22022-04-05
NFT22020-09-25
DKZ22004-05-17
JHI21999-07-22
JLW21999-06-22
NGL12024-05-22
DIO12017-06-02
DKX12003-06-13
DRR12002-12-19
DJR12002-11-22
MMI12002-01-08
DCK12001-07-20
CDZ12000-10-02
DBF11999-09-24
DGC11999-09-21
ETA11999-08-09
KLI11999-06-02
CDP11999-06-02

PMN#

GUDID#

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