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

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
00810173656139Healgen - K243365 AMP1000/BAR300/BZO300/COC300/MET1000/MDMA500/OPI2000/MTD300/OXY100/PCP257137338088Bryan.fang@healgen.com
00810173656177Healgen - K2433655 Panel Two-sided Cup: AMP1000, COC300, MET1000, OPI2000,THC507137338088Bryan.fang@healgen.com
00810173656344Healgen - K24336513 Panel Cup #31: AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC507137338088Bryan.fang@healgen.com
00810173656351Healgen - K24336510 Panel Cup #31: AMP1000, BAR300, BZO300, COC300, MET1000, MTD300, OPI2000, OXY100, PCP25, THC507137338088Bryan.fang@healgen.com
00810173656399Healgen - K2433656 Panel Cup Type #22 with Clicker: AMP1000, BZO300, COC300,MET1000, MOP300, THC507137338088Bryan.fang@healgen.com
00810173656405Healgen - K24068610 Panel DOA Dip Card: AMP1000, BAR300, BUP10, BZO300,COC300, MET1000, MTD300, OPI2000, OXY100, THC507137338088Bryan.fang@healgen.com
00810173656412Healgen - K2406869 Panel DOA Test Dip Card: AMP1000, BAR300, BZO300,COC300, MET1000, MTD300, OPI2000, PCP25, THC507137338088Bryan.fang@healgen.com
00810173656429Healgen - K2406866 Panel Dip Card: AMP1000, BZO300, COC300, MET1000,MOP300, THC507137338088Bryan.fang@healgen.com

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
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1338891944183436
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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#

GUDID#

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