Alere San Diego, Inc.

FDA Device Registration & Listing · San Diego, CA, US · Registration 2027969

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2027969
FEI Number
1000125596
Entity Name
Alere San Diego, Inc.
City/State/Country
San Diego, CA, US
Establishment Address
9942 Mesa Rim Road, 9942 Mesa Rim Road, San Diego, CA 92121, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K050050
PMA Number
N/A

All Registered 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) SureStep™ Urine Test Drug Screen Strip Bio-Rad TOX/See Drug Screen Test-PCP in Urine SureStep™ Urine Test Drug Screen Strip, Phencyclidine (PCP 25) iScreen™ Urine Test Drug Screen Dip Card 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) iScreen™ Urine Test Drug Screen Dip Card 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) iScreen™ Urine Test Drug Screen Dip Card SureStep™ Urine Test Drug Screen Strip, Opiate (MOP 300) SureStep™ Urine Test Drug Screen Strip 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) iScreen™ Urine Test Drug Screen Dip Card 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 SureStep™ Urine Test Drug Screen Strip 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) iScreen™ Urine Test Drug Screen Dip Card iCassette™ Urine Test Drug Screen Cassette mAMP One Step Methamphetamine Test Device Bio-Rad TOX/See Drug Screen Test-MET iScreenTM Urine Test Drug Screen Dip Card SureStep™ Urine Test Drug Screen Strip CERTUM mAMP One Step Methamphetamine Test Strip 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 iScreenTM Urine Test Drug Screen Dip 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 iCassette™ Urine Test Drug Screen Cassette iScreen™ Urine Test Drug Screen Dip Card CERTUM AMP One Step Amphetamine Test Strip SureStep™ Urine Test Drug Screen 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 SureStep™ Urine Drug Test Cassette 1 Step Detects DTX THC One Step Marijuana Single Drug Test (Urine) THC One Step Marijuana Test Device SureStep™ Urine Test Drug Screen Strip iCassette™ Urine Test Drug Screen Cassette 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) iScreen™ Urine Test Drug Screen Dip Card 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 Strip SureStep™ Urine Test Drug Screen Cassette, Methylenedioxymethamphetamine (MDMA 500) iScreen™ Urine Test Drug Screen Dip Card iCassette™ Urine Test Drug Screen Cassette SureStep™ Urine Drug Test Cassette 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 iScreen™ Urine Test Drug Screen Dip Card 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) iCassetteTM Urine Test Drug Screen Cassette JANT Pharmacal Accutest One Step Multi-Drug Multi-Line Screen Test Device One Step Multi-Drug Multi-Line Screen Test Device - CLIA Waived 1 Step Detects DTX One Step Multi-Drug Multi-Line Screen Test Device iCassette™ Urine Test Drug Screen Cassette - CLIA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-11-20
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-11-20
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2006-04-19
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2008-11-20
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2008-11-20
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2008-11-20
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2008-11-20
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2008-11-20
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2008-11-20
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2008-11-20
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2008-11-20
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2008-11-20
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-11-20
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2008-11-20
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2008-11-20
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-11-20
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2007-07-09
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2008-11-20
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2023-12-18
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2023-12-18
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2023-12-18
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2023-12-18
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2023-12-18
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2006-04-19
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2006-04-19
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2006-04-19
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2011-01-19
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2008-11-20
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2008-11-20
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2008-11-20
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2008-11-20
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2008-11-20
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2008-11-20
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2008-11-20
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2008-11-20
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2008-11-20
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2008-11-20
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-11-20
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-12-03
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2006-04-19
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2018-04-06
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2018-04-06
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2018-04-06
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2007-07-09
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2006-04-19
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2008-11-20
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2008-11-20
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-11-20
MRS Test System, Nicotine, Cotinine, Metabolites Clinical Toxicology Class 1 862.3220 2012-03-05
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2007-11-12
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2007-11-12
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2007-11-12
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2007-11-12
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2007-11-12
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2007-11-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964536 Teco Diagnostics ONE-STEP DIPSTICK PREGNANCY TEST 1997-02-11
K904016 Bhc Biotech , Ltd. MAXI TEST 1990-10-15
K870259 Leeco Diagnostics, Inc. VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 1987-03-10
K820822 Hybritech, Inc. TANDEM HCG KIT 1982-04-29
K153050 Co-Innovation Biotech Co., Ltd. Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 2016-04-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010 Biosite Inc 2
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010 Biosite Inc 2
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0029-2013 Alere San Diego, Inc. 2
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027969. Last updated year: 2026. Please use registration number 2027969 when referencing this establishment in official correspondence.
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