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

REAGENT, OCCULT BLOOD (KHE) (5) ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS (GQG) (1) ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. (GTY) (1) ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C (GNX) (1) FLUOROMETER, FOR CLINICAL USE (KHO) (1) Visual, pregnancy hCG, prescription use (JHI) (1)

Premarket Exempt

No Yes

Clear

QuickVue - 30014613201960 Catalog Number : 20196

Device Description : QuickVue iFOB Collect Kit 10T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201977 Catalog Number : 20197

Device Description : QkVue iFOB Control Set

Device Class : 2

Duns Number: 079509836

Premarket Exempt : Yes

Product Code : KHE

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613202011 Catalog Number : 20201

Device Description : QuickVue iFOB Tray Pack 50T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613202042 Catalog Number : 20204

Device Description : QuickVue iFOB Collect Kit 40T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613202059 Catalog Number : 20205

Device Description : QuickVue iFOB Test Dev Kit 100T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202189 Catalog Number : 20218

Device Description : Sofia Flu A+B 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GNX

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202219 Catalog Number : 20221

Device Description : Sofia Analyzer

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613202226 Catalog Number : 20222

Device Description : QkVue RSV 10, 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GQG

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202295 Catalog Number : 20229

Device Description : Sofia hCG 50T, US

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202318 Catalog Number : 20231

Device Description : Sofia Strep A 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

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