ALERE SAN DIEGO, INC.

ALERE SAN DIEGO, INC.

Address:829 Towne Center Drive,Pomona,CA,91767,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Immunoassay, Barbiturate (DIS) (3) Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (MLK) (3) Enzyme Immunoassay, Opiates (DJG) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (3) Enzyme Immunoassay, Amphetamine (DKZ) (3) Enzyme Immunoassay, Methadone (DJR) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (2) Enzyme Immunoassay, Phencyclidine (LCM) (2) Test,Natriuretic Peptide (NBC) (2) Radioimmunoassay, Cannabinoid(S) (LAT) (1) Analyzer, Chemistry, Micro, For Clinical Use (JJF) (1) Colorimetric Method, Triglycerides (JGY) (1) Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. (GMO) (1) Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (DAP) (1) Fluorometric Method, Cpk Or Isoenzymes (JHX) (1) Giardia Spp. (MHI) (1) Immunoassay Method, Troponin Subunit (MMI) (1) Myoglobin, Antigen, Antiserum, Control (DDR) (1) Cryptosporidium Spp. (MHJ) (1) Colorimetry, Acetaminophen (LDP) (1) Enzyme Immunoassay, Cocaine (JXO) (1)

Premarket Exempt

No Yes

Clear

Alere Cholestech LDX® - 00854361008003 Catalog Number : 14875

Device Description : Alere Cholestech LDX® Analyzer

Device Class : 1

Duns Number: 194854949

Premarket Exempt : No

Product Code : JJF

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002098 Catalog Number : 90008

Device Description : Alere Triage® 8 Panel for Drugs of Abuse

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : MLK, LDJ, DIS, DJG, DKZ, DIO, JXM, DJR

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002104 Catalog Number : 92000

Device Description : Alere Triage® Drugs of Abuse Panel Plus TCA

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : MLK, DIS, DJG, LDJ, DKZ, DIO, JXM, LCM

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002135 Catalog Number : 94400

Device Description : Alere Triage® TOX Drug Screen

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : MLK, LDJ, LCM, DJG, DJR, JXO, JXM, DIS, LAT, DKZ, LDP

Prescription Use : Yes

Device Count : 1

Triage® - 00893038002180 Catalog Number : 96100

Device Description : Triage® Micro Parasite Panel

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : GMO, MHJ, MHI

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002197 Catalog Number : 97000HS

Device Description : Alere Triage® Cardiac Panel

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : DDR, MMI, JHX

Prescription Use : Yes

Device Count : 1

Alere Cholestech LDX® - 00893038002210 Catalog Number : 88769

Device Description : Alere Cholestech LDX® Multianalyte Controls (2 X 2ml)

Device Class : 1

Duns Number: 194854949

Premarket Exempt : No

Product Code : JGY

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002289 Catalog Number : 98000XR

Device Description : Alere Triage® BNP Test

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002326 Catalog Number : 98100

Device Description : Alere Triage® D-Dimer Test

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : DAP

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002364 Catalog Number : 98200

Device Description : Alere Triage® BNP Reagent Packs

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

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