FDA.reportPublic FDA data

Alere San Diego, Inc.

Matched from indexed company URL: Alere, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20209522020952Alere San Diego, Inc.1Y2026-01-01829 Towne Center Dr Pomona CA US 91767
20279691000125596Alere San Diego, Inc.1N2026-01-019942 Mesa Rim Road 9942 Mesa Rim Road San Diego CA US 92121
20209522020952Alere San Diego Inc.1Y2020-04-25829 Towne Center Drive Pomona CA US 91767
20279691000125596Alere San Diego, Inc.1Y2020-04-259975 SUMMERS RIDGE RD SAN DIEGO CA US 92121
30051285633005128563ALERE (SHANGHAI) DIAGNOSTICS CO., LTD.1N2020-04-25NO. 151 LIBING ROAD No. 3728, JINKE ROAD SHANGHAI Shanghai CN 201203

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
00893038002012Cholestech LDX™ - Cholestech LDX™ Multianalyte Controls (2 X 2ml)+18774417440USproductsupport@abbott.com
00893038002029Cholestech LDX™ - Cholestech LDX™ Multianalyte Calibration Verification+18774417440USproductsupport@abbott.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
138301690299381K993317ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)JHI1999-12-01
3469571690299381K993317ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)JHI1999-12-01
138301638965470K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)JHI1999-12-01
3469571638965470K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)JHI1999-12-01
138301630342626K993065ACON COMBO PREGNANCYJHI1999-10-08
3469571630342626K993065ACON COMBO PREGNANCYJHI1999-10-08
138211552841715K991466EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)CEP1999-05-25
138211689934616K981271CLEARPLAN EASY OVULATION TESTCEP1998-06-25
138211054751680K981207CLEARPLAN EASY FERTILITY MONITORNGE1998-10-28
138301060951106K973784TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTSDKZ1997-12-03
1894081121899836K942435SALIVA SAMPLERPJD1995-08-21
138301095996460K934340BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTSLFI1994-12-02
138301650507695K902924BIOSITE DIAGNOSTICS OPIATE SCREENING TESTDJG1990-09-14
3469491301833306K223781Quantisal™ II Oral Fluid Collection DevicePJD2023-07-28
3469571425236626K223179Cholestech LDX ™ SystemCGA2023-09-20
3469491767425920K203527Immunalysis Tapentadol Urine HEIADJG2022-05-09
3469491195830151K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayLCM2021-04-20
1894081111191983K190397Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK2019-11-15
3469491111191983K190397Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAQBK2019-11-15
1894081903920553K183048Quantisal II Oral Fluid Collection DevicePJD2019-07-29
1894081353571752K181553Immunalysis Ethyl Alcohol Enzyme AssayDIC2018-10-31
3469491353571752K181553Immunalysis Ethyl Alcohol Enzyme AssayDIC2018-10-31
138211489390852K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)JHI2017-12-22
1894081046115160K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS2016-10-14
3469491046115160K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS2016-10-14
1894081330741839K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsDJG2017-06-14
3469491330741839K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsDJG2017-06-14
1894081576790142K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF2016-03-18
3469491576790142K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF2016-03-18
1894081446235219K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM2015-09-04
3469491446235219K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM2015-09-04
138301877872769K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood OnlyLYR2015-08-12
1894081477108247K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM2016-01-05
3469491477108247K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM2016-01-05
1894081731950060K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control SetsDJR2015-07-24
3469491731950060K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control SetsDJR2015-07-24
1894081927960576K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control SetLDJ2015-06-05
3469491927960576K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control SetLDJ2015-06-05
1894081597333591K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control SetDIO2015-06-29
3469491597333591K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control SetDIO2015-06-29
1894081036650033K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine ControlsDJG2015-03-09
3469491036650033K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine ControlsDJG2015-03-09
1894081850933789K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug ControlsDJG2015-05-20
3469491850933789K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug ControlsDJG2015-05-20
1894081337306454K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control SetDKZ2015-02-06
3469491337306454K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control SetDKZ2015-02-06
1894082026553047K141803IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAYDJG2015-02-12
3469492026553047K141803IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAYDJG2015-02-12
1894081345031857K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORSDJG2014-07-01
3469491345031857K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORSDJG2014-07-01
1894081089169722K131168IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAYDJG2014-01-17
3469491089169722K131168IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAYDJG2014-01-17
138301978832971K120615ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTECGA2013-05-15
138211199178511K112870
138211581064942K110433CLEARBLUE EASY PREGNANCY TESTLCX2011-05-12
138301770236369K102700LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALSJJY2010-12-21
3469571770236369K102700LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALSJJY2010-12-21
138301952616054K062361INNOVACON HCG UKTRA TEST DEVICEJHI2006-10-23
3469571952616054K062361INNOVACON HCG UKTRA TEST DEVICEJHI2006-10-23
138211592167143K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTLCX2006-07-03
138301097663091K061718INNOVACON SPECTRUM II TEST CARDDKZ2006-11-13
3469571097663091K061718INNOVACON SPECTRUM II TEST CARDDKZ2006-11-13
138301022440431K060466ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICEDJG2006-04-21
3469571022440431K060466ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICEDJG2006-04-21
138301544415299K060133ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SETJJX2006-02-16
138211282176100K060128CLEARBLUE EASY DIGITAL PREGNANCY TESTLCX2006-05-25
138301875673542K050878ON CALL MULTI-DRUG HOME TEST CUPLDJ2005-06-08
3469571875673542K050878ON CALL MULTI-DRUG HOME TEST CUPLDJ2005-06-08
138301843804550K050050ON CALL MULTI-DRUG HOME TESTLDJ2005-03-11
3469571843804550K050050ON CALL MULTI-DRUG HOME TESTLDJ2005-03-11
138301046655073K043507ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICEDJG2005-02-25
3469571046655073K043507ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICEDJG2005-02-25
138212033451644K042280FACT PLUS ONE-STEP PREGNANCY TEST KITLCX2004-09-10
138301364542219K042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)KTN2005-02-28
138301958097027K041822ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICEDKZ2004-09-16
3469571958097027K041822ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICEDKZ2004-09-16
138301705456854K041685ACON MULTI-CLIN DRUG SCREEN TEST DEVICEDKZ2004-08-30
3469571705456854K041685ACON MULTI-CLIN DRUG SCREEN TEST DEVICEDKZ2004-08-30
138301938858498K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEJXN2004-05-19
3469571938858498K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEJXN2004-05-19
138211756025403K040341CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TESTLCX2004-03-08
138211038984190K040329MODIFICATION TO E.P.T. PREGNANCY TESTLCX2004-03-08
138301249661940K033299ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICELAF2003-12-12
3469571249661940K033299ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICELAF2003-12-12
138301251658342K032903ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICEDIO2004-02-17
3469571251658342K032903ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICEDIO2004-02-17
138211204606622K030659CLEARBLUE EASY DIGITAL PREGNANCY TESTLCX2003-05-02
138301566799004K024350ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICELYR2003-04-02
138301071022724K022589ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICELAF2002-10-28
3469571071022724K022589ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICELAF2002-10-28
138301448474513K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICELFG2002-07-17
3469571448474513K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICELFG2002-07-17
138301194676382K014247TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002DKZ2002-06-03
138211866125412K013907INVERNESS MEDICAL EARLY PREGNANCY TESTLCX2001-12-18
138301358184298K013380ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICEDJG2001-12-18
3469571358184298K013380ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICEDJG2001-12-18
138301152941964K012824ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICEDIS2001-11-09
3469571152941964K012824ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICEDIS2001-11-09
138301871200661K012595ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICEDJR2001-10-15
3469571871200661K012595ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICEDJR2001-10-15
138301880985851K012300ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICEJXM2001-09-17
3469571880985851K012300ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICEJXM2001-09-17
138301553562460K011730ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICELCM2001-08-09
3469571553562460K011730ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICELCM2001-08-09
138301405708058K011673ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICEDKZ2001-07-31
3469571405708058K011673ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICEDKZ2001-07-31
138301630585860K011672ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICELAF2001-07-31
3469571630585860K011672ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICELAF2001-07-31
138301814729924K011353ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICEDJG2001-07-30
3469571814729924K011353ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICEDJG2001-07-30
138301180327050K010841ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICEDIO2001-07-09
3469571180327050K010841ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICEDIO2001-07-09
138301574029059K010582ACON STREP A RAPID TEST STRIPGTY2001-05-07
3469571574029059K010582ACON STREP A RAPID TEST STRIPGTY2001-05-07
138301725968253K003557ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)LDJ2001-03-15
3469571725968253K003557ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)LDJ2001-03-15
138211000998123K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTCEP2000-10-12
138211106105295K002049INVERNESS MEDICAL EARLY PREGNANCY TESTLCX2000-07-27
1894081010224007
1894081078154003

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG222022-05-09
DKZ122015-02-06
JHI92017-12-22
LCX92011-05-12
LAF82016-03-18
LDJ82015-06-05
DIO62015-06-29
LCM52021-04-20
DIS42016-10-14
JXM42016-01-05
DJR42015-07-24
PJD32023-07-28
CEP32000-10-12
CGA22023-09-20
QBK22019-11-15
DIC22018-10-31
LYR22015-08-12
JJY22010-12-21
JXN22004-05-19
LFG22002-07-17
GTY22001-05-07
JJX12006-02-16
KTN12005-02-28
NGE11998-10-28
LFI11994-12-02

PMA#

PMN#

GUDID#

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