FDA.reportPublic FDA data

LUMIQUICK DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059840813005984081LUMIQUICK DIAGNOSTICS, INC.1Y2027-01-012946 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
674321043763984
674321055478584
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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