QUIDEL CARDIOVASCULAR INC.

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

Single (specified) analyte controls (assayed and unassayed) (JJX) (7) Multi-analyte controls, all kinds (assayed) (JJY) (3)

Premarket Exempt

No Yes

Clear

Triage - 30014613337010 Catalog Number : 98013XR

Device Description : Triage BNP Control 1

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Triage - 30014613337027 Catalog Number : 98014XR

Device Description : Quidel Triage® BNP Control 2

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Triage - 30014613337034 Catalog Number : 98015XR

Device Description : Quidel Triage® BNP Calibration Verification

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Triage - 30014613337041 Catalog Number : 98713EU

Device Description : Triage NT-proBNP Control 1

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Triage - 30014613337058 Catalog Number : 98714EU

Device Description : Triage NT-proBNP Control 2

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Triage - 30014613337065 Catalog Number : 98813EU

Device Description : Triage PLGF Control 1

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Triage - 30014613337072 Catalog Number : 98814EU

Device Description : Triage PLGF Control 2

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Triage - 30014613337089 Catalog Number : 88733

Device Description : Quidel Triage Total 3 Control 1

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Triage - 30014613337096 Catalog Number : 88734

Device Description : Quidel Triage Total 3 Control 2

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Triage - 30014613337102 Catalog Number : 88753

Device Description : Quidel Triage Total 5 Control 1

Device Class : 1

Duns Number: 080890141

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

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