FDA.reportPublic FDA data

GERMAINE LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16496613001451797GERMAINE LABORATORIES, INC.1N2026-01-0111030 Wye Drive SAN ANTONIO TX US 78217

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
00695684773014AimStrip Tandem Lipid Profile and glucose measuring system - Lipid and Glucose Measuring System1-800-854-8446sales@germainelabs.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
538922023583110K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
538921159142977K981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TESTJHI1998-04-16
538922047667200K980531AIMSTEP PREGNANCYJHI1998-03-06
538921131508037K974512AIMSTICK PBD COMBO PREGNANCYDHA1998-01-02
538921520484209K974368AIMSTICK PBD PREGNANCYDHA1998-01-02
538921976304035K973825MIDSTREAM HOME REGNANCY TESTDHA1997-12-19
538921813710655K864731OCEAN SCIENTIFIC VDRL TESTGMQ1987-03-10
538921001573648K863849LIQUI-SERA COMBO LIGAND/TDM CONTROLSJJY1986-11-24
538921943974880K821388SERO/TEX CRP TESTDCN1982-07-02
538921427156428K821319SERO/TEX RF TESTDHR1982-05-21
538921950235987K252283Nano-Check Influenza A+B TestPSZ2026-01-15
538921340855761K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT2025-02-27
538921909249892K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupNGL2024-12-17
538921124747480K233417AllTest Fentanyl Urine Test CassetteNGL2023-10-26
538921123155273K180504Mission Lipid Panel Monitoring SystemCHH2018-03-28
538921527780869K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2016-05-23
538921985174485K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM2015-08-13
538921713388716K151348Healgen 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
538922059866989K150330Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR2015-04-30
538921252463349K133343WONDFO RAPID STREP A TESTGTY2014-01-31
538921940857906K130295LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.NBW2013-06-21
538921256687293K122553MISSION PLUS HB HEMOGLOBIN TESTING SYSTEMGKR2013-08-05
538921973781112K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLDIF2012-07-03
538921891934328K120124FORESIGHT U120 URINE ANALYZERJIL2012-03-06
538921444637067K111221MISSION U500 URINE ANALYZERJIO2012-01-18
538921002056735K103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLJJW2011-02-02
538921289882563K102664HEMA SCREEN ERKHE2011-01-28
538921448843791K093879MISSION SALIVA ALCOHOL TEST STRIPDIC2010-08-06
538921058602403K093143MISSION BREATH ALCOHOL DETECTORDJZ2010-01-28
538921865785752K090057ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEMNBW2009-04-08
538921052323018K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2JJY2008-09-17
538921279870861K070929ACON U120 URINE ANALYZER, MODEL U111-101KQO2007-07-30
538921844713804K070660INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TESTKHE2007-06-21
538921037609248K063693FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TESTKHE2007-05-11
538921172284527K061559ACON URINALYSIS REAGENT STRIPSCDM2006-08-11
538921762927702K051727AIMSTICK URINE REAGENT STRIPSCEN2005-10-26
538921333290303K042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)KTN2005-02-28
538922072577103K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEJXN2004-05-19
538921747072623K040274ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICEDJG2004-05-03
538921942009606K030912THYRO TESTJLW2003-07-25
538921960637413K024360INSTANT-VIEW H. PYLORI ONE STEP RAPID TESTLYR2003-06-10
538921945084263K024350ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICELYR2003-04-02
538922067989456K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICELFG2002-07-17
538921300497029K013857AIMSTEP PREGNANCYDHA2002-01-22
538921636170657K012824ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICEDIS2001-11-09
538921583371249K012595ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICEDJR2001-10-15
538921556962318K012300ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICEJXM2001-09-17
538921031848565K011730ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICELCM2001-08-09
538921084976466K011673ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICEDKZ2001-07-31
538921856544325K011672ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICELAF2001-07-31
538921828221583K010841ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICEDIO2001-07-09
538921820458084K010582ACON STREP A RAPID TEST STRIPGTY2001-05-07
538921261453294K003557ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)LDJ2001-03-15
538921015793984
538921078549713
538921133591726
538921158759040
538921247020337
538921265495536
538921275243566
538921408061064
538921475789346
538921509470427
538921511352976
538921565059935
538921657327267
538921711221561
538921742366750
538921772652739
538921810770205
538921838972796
538921989722442
538922028057896

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DHA42002-01-22
JXM32016-05-23
GTY32014-01-31
KHE32011-01-28
NGL22024-12-17
LFG22015-08-18
NBW22013-06-21
JJY22008-09-17
LYR22003-06-10
JHI21998-04-16
PSZ12026-01-15
NFT12025-02-27
CHH12018-03-28
JIR12015-04-30
GKR12013-08-05
DIF12012-07-03
JIL12012-03-06
JIO12012-01-18
JJW12011-02-02
DIC12010-08-06
DJZ12010-01-28
KQO12007-07-30
CDM12006-08-11
CEN12005-10-26
KTN12005-02-28
JXN12004-05-19
DJG12004-05-03
JLW12003-07-25
DIS12001-11-09
DJR12001-10-15
LCM12001-08-09
LAF12001-07-31
DKZ12001-07-31
DIO12001-07-09
LDJ12001-03-15
GMQ11987-03-10
DCN11982-07-02
DHR11982-05-21

PMN#

GUDID#

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