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, Cocaine (JXO) (4) Radioimmunoassay, Cannabinoid(S) (LAT) (4) Enzyme Immunoassay, Opiates (DJG) (4) Enzyme Immunoassay, Amphetamine (DKZ) (4) Enzyme Immunoassay, Barbiturate (DIS) (4) Enzyme Immunoassay, Benzodiazepine (JXM) (4) Enzyme Immunoassay, Cannabinoids (LDJ) (4) Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (MLK) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) Immunoassay Method, Troponin Subunit (MMI) (3) System, Test, Infectious Mononucleosis (KTN) (2) Enzyme Immunoassay, Methadone (DJR) (2) Fluorometric Method, Cpk Or Isoenzymes (JHX) (2) Colorimetric Method, Triglycerides (JGY) (1) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (1) Myoglobin, Antigen, Antiserum, Control (DDR) (1) Colorimetry, Acetaminophen (LDP) (1) Test,Natriuretic Peptide (NBC) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (DAP) (1) Glucose Oxidase, Glucose (CGA) (1)

Premarket Exempt

No Yes

Clear

Alere Triage® - 00899722002740 Catalog Number : 97300EU

Device Description : Alere Triage® Profiler SOB™ Panel

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : NBC, DAP, DDR, MMI, JHX

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00899722002757 Catalog Number : 94400EU

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

Alere Triage® - 00899722002764 Catalog Number : 94401

Device Description : Alere Triage® TOX Drug Screen – 10 Tests

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00899722002771 Catalog Number : 94402

Device Description : Alere Triage® TOX Drug Screen – 9 Tests

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00899722002788 Catalog Number : 97021HS

Device Description : Alere Triage® Cardiac Panel, TnI

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : MMI

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00899722002795 Catalog Number : 97022HS

Device Description : Alere Triage® Cardiac Panel, CK-MB and TnI

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : MMI, JHX

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00899722002856 Catalog Number : 94404

Device Description : Alere Triage® TOX Drug Screen – 7 Tests

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : LDJ, DJG, JXO, JXM, DIS, LAT, DKZ

Prescription Use : Yes

Device Count : 1

Alere Cholestech LDX® - 04571226470831 Catalog Number : 14-531

Device Description : Alere Cholestech LDX® Lipid Profile●GLU

Device Class : 1

Duns Number: 194854949

Premarket Exempt : No

Product Code : CGA, JGY, LBS, CHH

Prescription Use : Yes

Device Count : 1

Clearview® - 10815845020000 Catalog Number :

Device Class :

Duns Number: 194854949

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 30

Acceava® - 10815845020017 Catalog Number :

Device Class :

Duns Number: 194854949

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 25

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