QUIDEL CORPORATION

Address:2285 Rutherford Road,Carlsbad,CA,92008,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

Coronavirus antigen detection test system. (QKP) (1) FLUOROMETER, FOR CLINICAL USE (KHO) (1)

Premarket Exempt

No Yes

Clear

QuickVue - 30014613339724 Catalog Number : 20402

Device Description : QuickVue At-Home OTC COVID-19 Test

Device Class :

Duns Number: 079509836

Premarket Exempt : No

Product Code : QKP

Prescription Use : No

Device Count : 1

Sofia - 30014613802211 Catalog Number : 20221R

Device Description : Sofia Analyzer, Reconditioned

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

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