BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alere San Diego, Inc.

    Reg #: 2027969 · FEI: 1000125596 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    159
    Establishment Types
    3
    Classifications
    27

    Registration Details

    Registration Name
    Alere San Diego, Inc.
    Registration Number
    2027969
    FEI Number
    1000125596
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9942 Mesa Rim Road, 9942 Mesa Rim Road
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993203

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Visual, Pregnancy Hcg, Prescription Use JHI
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Phencyclidine LCM
    Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Barbiturate DIS
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Test, Opiates, Over The Counter NGL
    Antigens, All Groups, Streptococcus Spp. GTY
    Glucose Oxidase, Glucose CGA
    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl LBS
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Colorimetric Method, Triglycerides JGY
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Enzyme Immunoassay, Methadone DJR
    Thin Layer Chromatography, Methamphetamine DJC
    Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica JQT
    Assay, Glycosylated Hemoglobin LCP
    Enzymatic Method, Creatinine JFY
    Test System, Nicotine, Cotinine, Metabolites MRS
    Enzyme Controls (Assayed And Unassayed) JJT
    Hemoglobin A1c Test System PDJ

    Proprietary Names

    Henry Schein One Step+ hCG Urine Strip Test Sure-Vue Urine hCG Strip McKesson CONSULT hCG Urine Test Dipstick CLIA Waived Pro Advantage by NDC Urine Pregnancy Test Strip Medline hCG Pregnancy Test Strip Alere hCG Dipstick (25mIU/mL) in Urine Cardinal Health hCG Dipstick Rapid Test CLIA Waived SureStep™ Urine Test Drug Screen Strip, Oxycodone (OXY 100) Oxycodone One Step Oxycodone Test Device OXY One Step Oxycodone Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-OXY for Urine iScreen™ Urine Test Drug Screen Dip Card iCassette™ Urine Test Drug Screen Cassette 1 Step Detects DTX OXY One Step Oxycodone Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip PCP One Step Phencyclidine Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-PCP in Urine SureStep™ Urine Test Drug Screen Strip, Phencyclidine (PCP 25) Signify™ ER Urine Test Drug Screen Cassette - CLIA iCassette™ Urine Test Drug Screen Cassette - CLIA CLIA Waived multi-CLIN™ Drug Screen Test Device JANT Pharmacal Accutest MultiDrug ER II Drug Screen Test Device SureStep™ Urine Test Drug Screen Strip, Cocaine (COC 150) CERTUM COC One Step Cocaine Test Strip SureStep™ Urine Test Drug Screen Cassette, Cocaine (COC 150) SureStep™ Urine Drug Test Cassette MOP One Step Opiate Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Opiate (MOP 300) SureStep™ Urine Test Drug Screen Cassette, Opiate (MOP 300) HENRY SCHEIN One Step+ Strep A Dipstick Test Alere Acceava Strep A Fisher Scientific Sure-Vue Strep A Test Clearview Strep A Exact II Dipstick Pro Advantage by NDC Strep A Test- Throat Swab Immunostics Inc. Detector Strep A McKesson CONSULT Strep A Tests Dipstick Cardinal Health Strep A Dipstick Rapid Test Medline Strep A Dipstick Stanbio QuStick Strep A Rapid Test Strip Procedure No. 6000 CLIA Waived CERTUM mAMP One Step Methamphetamine Test Strip SureStep™ Urine Test Drug Screen Strip, Methamphetamine (MET 500) Cholestech™ LDX Analyzer Cholestech™ LDX TC HDL GLU Cholestech™ LDX TC/HDL Cholestech™ LDX Lipid Profile Cholestech™ LDX TC GLU Cholestech™ LDX TC Cholestech™ LDX Lipid Profile GLU PPX One Step Propoxyphene Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-PPX for Urine SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300) BZO One Step Benzodiazepines Test Device CERTUM BZO One Step Benzodiazepines Test Strip 1 Step Detects DTX BZO One Step Benzodiazepimes Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Benzodiazepines (BZO 300) BZO One Step Benzodiazepines Single Drug Test (Urine) mAMP One Step Methamphetamine Test Device Bio-Rad TOX/See Drug Screen Test-MET iScreenTM Urine Test Drug Screen Dip Card 1 Step Detects DTX mAMP One Step Methamphetamine Single Drug Test (Urine) SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000) mAMP One Step Methamphetamine Single Drug Test (Urine) Cholestech LDX™ Multianalyte Calibration Verification Cholestech LDX™ Multianalyte Controls (2 X 2ml) Cholestech LDX™ Multianalyte Controls (2 X 250µL) SureStepTM Urine Test Drug Screen Dip Card SureStepTM Urine Drug Test Dipcard iScreenTM Urine Test E-Z Split KeyTM Drug Screen Cup Jant Pharmacal Accutest One Step Drug Screen Test Card for Multi-Drugs Bio-Rad TOX/See Drug Screen Test for Multiple Drugs One Step Drug Screen Test Card SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup CERTUM One Step Multi-Line Drug Screen EZ Split mCupTM Urine Test Drug Screen Cup iCassetteTM Urine Test Drug Screen Cassette CERTUM One Step Multi-Drug Screen Panel Express Results™ Multi-Drug Screen Card iCupTM Urine Test Drug Screen Cup Express Results™ Integrated Multi-Drug Screen Cup One Step Multi-Drug Multi-Line Screen Test Device Noble Medical Split-Specimen Cup 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device Jant Pharmacal Accutest Integrated E-Z Split Key Cup II for Multi-Drugs Integrated E-Z Split Key Cup II for Multi-Drugs McKesson CONSULT Diagnostics hCG Combo Tests Cassette Cardinal Health hCG Combo Rapid Test Alere hCG Cassette (20 mIU/mL) in Urine McKesson CONSULT Diagnostics hCG Urine Tests Cassette Sure-Vue Serum/Urine hCG-STAT Medline hCG Combo+ Pregnancy Test Cassette Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum BIO-RAD TOX/See Drug Screen Test-AMP CERTUM AMP One Step Amphetamine Test Strip SureStep™ Urine Test Drug Screen Cassette, Amphetamine (AMP 1000) AMP One Step Amphetamine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Amphetamine (AMP 1000) Afinion HbA1c Afinion ACR Afinion 2 Henry Schein, Inc. One Step + Urine Cassette Test Alere hCG Cassette (25mIU/mL) in Urine Cardinal Health hCG Cassette Rapid test CLIA Waived Sure-Vue Urine hCG Medline HCG Pregnancy Test Cassette Pro Advantage By NDC Urine Pregnancy Cassette Device 1 Step Detects DTX THC One Step Marijuana Single Drug Test (Urine) THC One Step Marijuana Test Device THC One Step Marijuana Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Marijuana (THC 50) SureStep™ Urine Test Drug Screen Cassette, Marijuana (THC 50) Bio-Rad TOX/See Drug Screen Test-THC for Urine CERTUM THC One Step Marijuana Test Strip SureStep™ Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500) Bio-Rad TOX/See Drug Screen Test-MDMA MDMA One Step Ecstasy Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Cassette, Methylenedioxymethamphetamine (MDMA 500) ICON 25 hCG Immunochemical Test for hCG in Urine (CLIA Waived) and Serum Sure-Vue Serum/Urine hCG Beckman Coulter Inc's ICON 25 hCG Henry Schein One Step+ hCG Combo test in Serum or Urine Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum Pro Advantage by NDC Urine/Serum Pregnancy Cassette Device Bio-Rad TOX/See Drug Screen Test-BUP 1 Step Detects DTX BUP One Step Buprenorpine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Buprenorphine (BUP10) BUP One Step Buprenorphine Test Device BUP One Step Buprenorphine Single Drug test (Urine) iScreenTM Oral Fluid Test Drug Screen Pad JANT Pharmacal Accutest COT One Step Cotinine Test Device in Urine COT One Step Cotinine Urine Test Device in Urine SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) JANT Pharmacal Accutest One Step Multi-Drug Multi-Line Screen Test Device One Step Multi-Drug Multi-Line Screen Test Device - CLIA Waived JANT Pharmacal Accutest Integrated E-Z Split Key Cup II Integrated E-Z Split Key Cup II Cholestech LDX™ Accessories (Optics Check Cassette) Bio-Rad TOX/See Drug Screen Test-COC COC One Step Cocaine Test Device 1 Step Detects DTX COC One Step Cocaine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Cocaine (COC 300) COC One Step Cocaine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Cassette, Amphetamine (AMP 300) SureStep™ Urine Test Drug Screen Strip, Amphetamine (AMP 300) AMP 300 One Step Amphetamine Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Cassette, Barbiturates (BAR 300) BAR One Step Barbiturates Single Drug Test (Urine) CERTUM BAR One Step Barbiturates Test Strip SureStep™ Urine Test Drug Screen Strip, Barbiturates (BAR 300) CERTUM OPI One Step Opiate Test Strip SureStep™ Urine Test Drug Screen Strip, Opiate (OPI 2000) OPI One Step Opiate Single Drug Test (Urine) 1 Step Detects DTX OPI One Step Opiate Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Test-TCA TCA One Step Tricyclic Antidepressants Single Drug Test (Urine) SureStep™ Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000) MTD One Step Methadone Single Drug Test (Urine) Bio-Rad TOX/See Drug Screen Tests -MTD SureStep™ Urine Test Drug Screen Strip, Methadone (MTD 300) Afinion HbA1c Dx

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)