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

Colorimetric Method, Triglycerides (JGY) (3) Immunoassay Method, Troponin Subunit (MMI) (3) Test,Natriuretic Peptide (NBC) (3) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (2) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (2) Fluorometric Method, Cpk Or Isoenzymes (JHX) (1) Glucose Oxidase, Glucose (CGA) (1) Myoglobin, Antigen, Antiserum, Control (DDR) (1) Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (DAP) (1)

Premarket Exempt

No Yes

Clear

Alere Triage® - 00893038002814 Catalog Number : 97500EU

Device Description : Alere Triage® Cardio2 Panel

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : NBC, MMI

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00893038002821 Catalog Number : 98600EU

Device Description : Alere Triage® Troponin I Test

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : MMI

Prescription Use : Yes

Device Count : 1

Alere Cholestech LDX® - 00893038002845 Catalog Number : 88773

Device Description : Alere Cholestech LDX® Multianalyte Controls

Device Class : 1

Duns Number: 194854949

Premarket Exempt : No

Product Code : JGY

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00899722002078 Catalog Number : 98800EU

Device Description : Alere Triage® PlGF Test

Device Class :

Duns Number: 194854949

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Alere Triage® - 00899722002177 Catalog Number : 98700EU

Device Description : Alere Triage® NT-proBNP Test

Device Class : 2

Duns Number: 194854949

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

Alere Cholestech LDX® - 00899722002337 Catalog Number : 99020

Device Description : Alere Cholestech LDX® Lipid Profile

Device Class : 1

Duns Number: 194854949

Premarket Exempt : No

Product Code : JGY, LBS, CHH

Prescription Use : Yes

Device Count : 1

Alere Cholestech LDX® - 00899722002344 Catalog Number : 99021

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

Alere Triage® - 00899722002702 Catalog Number : 98000XREU

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® - 00899722002719 Catalog Number : 97000HSEU

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 Triage® - 00899722002733 Catalog Number : 98100EU

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

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