QUIDEL CARDIOVASCULAR INC.

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

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Filters

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

TEST,NATRIURETIC PEPTIDE (NBC) (4) FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL (DAP) (2) IMMUNOASSAY METHOD, TROPONIN SUBUNIT (MMI) (2) Enzyme immunoassay, cannabinoids (LDJ) (1) Enzyme immunoassay, cocaine (JXO) (1) Enzyme immunoassay, methadone (DJR) (1) Enzyme immunoassay, opiates (DJG) (1) Drug mixture control materials (DIF) (1) FLUOROMETER, FOR CLINICAL USE (KHO) (1) Gas chromatography, methamphetamine (LAF) (1) Enzyme immunoassay, barbiturate (DIS) (1) Placental growth factor test (PZN) (1) Radioimmunoassay, tricyclic antidepressant drugs (LFG) (1) Enzyme immunoassay, benzodiazepine (JXM) (1)

Premarket Exempt

No Yes

Clear

Triage - 30014613337973 Catalog Number : 97500EU

Device Description : Triage Cardio2 Panel

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : NBC, MMI

Prescription Use : No

Device Count : 1

Triage - 30014613337980 Catalog Number : 98000XR

Device Description : Triage BNP Test

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

Triage - 30014613337997 Catalog Number : 98000XREU

Device Description : Triage BNP Test (OUS)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

Triage - 30014613338000 Catalog Number : 98100

Device Description : Triage D-Dimer Test

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : DAP

Prescription Use : Yes

Device Count : 1

Triage - 30014613338017 Catalog Number : 98100EU

Device Description : Triage D-Dimer Test (OUS)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : DAP

Prescription Use : Yes

Device Count : 1

Triage - 30014613338024 Catalog Number : 98600EU

Device Description : Triage Troponin I Test (OUS)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 1

Triage - 30014613338031 Catalog Number : 98700EU

Device Description : Triage NT-proBNP Test (OUS)

Device Class : 2

Duns Number: 080890141

Premarket Exempt : No

Product Code : NBC

Prescription Use : Yes

Device Count : 1

Triage - 30014613338048 Catalog Number : 98800EU

Device Description : Triage PLGF Test (OUS)

Device Class :

Duns Number: 080890141

Premarket Exempt : No

Product Code : PZN

Prescription Use : Yes

Device Count : 1

Triage - 30014613338109 Catalog Number : 94600

Device Description : Triage TOX Drug Screen, 94600

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : LAF, KHO, DIS, JXM, LFG, LDJ, JXO, DJR, DJG

Prescription Use : Yes

Device Count : 1

Triage - 30014613338116 Catalog Number : 94613

Device Description : Triage TOX Drug Screen, 94600 Control 1

Device Class : 1

Duns Number: 080890141

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

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