QUIDEL CARDIOVASCULAR INC.

Address:9975 Summers Ridge Road,San Diego,CA,92121,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

IMMUNOASSAY METHOD, TROPONIN SUBUNIT (MMI) (6) FLUOROMETRIC METHOD, CPK OR ISOENZYMES (JHX) (5) Enzyme immunoassay, benzodiazepine (JXM) (4) Enzyme immunoassay, cannabinoids (LDJ) (4) Enzyme immunoassay, cocaine (JXO) (4) Enzyme immunoassay, opiates (DJG) (4) Gas chromatography, methamphetamine (LAF) (4) Enzyme immunoassay, amphetamine (DKZ) (4) Enzyme immunoassay, barbiturate (DIS) (4) Thin layer chroomatography, tricyclic antidepressant drugs (MLK) (3) Enzyme immunoassay, phencyclidine (LCM) (3) Enzyme immunoassay, methadone (DJR) (2) MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL (DDR) (2) TEST,NATRIURETIC PEPTIDE (NBC) (2) FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL (DAP) (1) RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP. (DOR) (1) COLORIMETRY, ACETAMINOPHEN (LDP) (1)

Premarket Exempt

No Yes

Clear

Triage - 30014613337874 Catalog Number : 94401

Device Description : Triage TOX Drug Screen (10 Panel)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Triage - 30014613337881 Catalog Number : 94402

Device Description : Triage TOX Drug Screen (9 Panel)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Triage - 30014613337898 Catalog Number : 94404

Device Description : Triage TOX Drug Screen (7 Panel)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Triage - 30014613337904 Catalog Number : 94400EU

Device Description : Triage TOX Drug Screen (OUS)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Triage - 30014613337911 Catalog Number : 97000HS

Device Description : Triage Cardiac Panel

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : MMI, JHX, DDR

Prescription Use : Yes

Device Count : 1

Triage - 30014613337928 Catalog Number : 97000HSEU

Device Description : Triage Cardiac Panel (OUS)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : DOR, MMI, JHX

Prescription Use : Yes

Device Count : 1

Triage - 30014613337935 Catalog Number : 97021HS

Device Description : Triage Cardiac Panel (TnI)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : MMI

Prescription Use : Yes

Device Count : 1

Triage - 30014613337942 Catalog Number : 97022HS

Device Description : Triage Cardiac Panel (CK/TnI)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : MMI, JHX

Prescription Use : Yes

Device Count : 1

Triage - 30014613337959 Catalog Number : 97300EU

Device Description : Triage Profiler SOB Panel (OUS)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Triage - 30014613337966 Catalog Number : 97400EU

Device Description : Triage Cardio3 Panel

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : MMI, JHX, NBC

Prescription Use : Yes

Device Count : 1

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