FDA.reportPublic FDA data

HEALGEN SCIENTIFIC LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30092382843009238284HEALGEN SCIENTIFIC LLC1Y2026-01-013818 Fuqua St Houston TX US 77047

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1338891476524280K260095Heal-Check Rapid COVID-19 Antigen Self-TestQYT2026-04-13
1338892003767826K253705Healgen® Accurate Oral Fluid Drug TestDJC2026-03-16
1338891126928347K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardNGL2025-12-23
1338891601109292K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestNFW2026-02-12
1338891902742443K251800Healgen® URS Test StripsJMT2025-12-23
1338891962853553K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupNGL2024-12-17
1338891158331719K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)NGL2024-05-13
1338891256751687K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardNGL2024-04-12
1338891927528465K232377Healgen Rapid COVID-19 Antigen TestQVF2024-04-19
1338891751148039K231045Healgen URS Test StripsLJX2023-06-16
1338891689985032K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ2023-03-17
1338891355969856K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup RxNFT2022-08-30
1338891274091175K212623Healgen Strep A Rapid Test Strip (Throat Swab)GTY2022-03-16
1338891658967422K212418hCG One Step Pregnancy TestLCX2022-06-30
1338891129072142K191841Accurate Multi Panel Drug Urine Test CupNFT2019-08-07
1338892019560102K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM2017-08-02
1338891344527181K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2016-05-23
1338891238416638K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)DKZ2015-09-09
1338891096121609K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2015-08-13
1338891382641452K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)LFG2015-08-18
1338891797577080K150791Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)DIS2015-04-24
1338891855354312K150356Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2015-05-13
1338891213682738K150096Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)LAF2015-03-04
1338891697999299K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)DJG2015-01-27
1338891419536159K142280Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)DJG2014-10-16
1338891172702139K141647HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)DIO2014-07-17
1338892050656083K140546HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TESTLDJ2014-06-06
1338891683714965K123703HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)LCX2013-04-10
1338891552803864K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALJIO2012-04-17
1338891388431005K110309FOB ONE STEP RAPID TESTKHE2011-09-14
1338891930826651K103574PREGNANCY ONE STEP RAPID TESTLCX2011-07-28
1338891626302914K021789QUICKLAB RSVGQG2002-11-20
1338891856040295DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestSCA2024-10-07
1338891086305508
1338891123112400
1338891199956005
1338891229374879
1338891239348586
1338891289725704
1338891326588901
1338891361507592
1338891374015698
1338891452424244
1338891523615239
1338891608976368
1338891619084914
1338891632885152
1338891651388913
1338891675707611
1338891680652365
1338891726102023
1338891811774669
1338891814141534
1338891822014060
1338891838101745
1338891887690911
1338891907121611
1338891940624923
1338891979525796
1338892052548307
1338892071151972
1338891013385491
1338891053666909
1338891062160515
1338891127386967
1338891255927377
1338891293478577
1338891293606299
1338891336418506
1338891361048778
1338891504638764
1338891514803895
1338891517036289
1338891531270349
1338891543475616
1338891563023549
1338891594688062
1338891686898438
1338891697127888
1338891706647840
1338891752260630
1338891769164034
1338891770245075
1338891797436486
1338891799180464
1338891813089340
1338891813517362
1338891840384996
1338891851973717
1338891873507912
1338891877763389
1338891904597012
1338891914663087
1338891917670082
1338891931004320
1338891939090757
1338891940847179
1338891943653246
1338891944183436
1338891963101520
1338891986589065
1338892021981249
1338892066664004

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NGL42025-12-23
JXM42017-08-02
LCX32022-06-30
LDJ22023-03-17
NFT22022-08-30
DJG22015-01-27
QYT12026-04-13
DJC12026-03-16
NFW12026-02-12
JMT12025-12-23
SCA12024-10-07
QVF12024-04-19
LJX12023-06-16
GTY12022-03-16
DKZ12015-09-09
LFG12015-08-18
DIS12015-04-24
LAF12015-03-04
DIO12014-07-17
JIO12012-04-17
KHE12011-09-14
GQG12002-11-20

PMN#