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

Visual, pregnancy hCG, prescription use (JHI) (3) ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. (GTY) (2) ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. (GTZ) (1) ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS (GQG) (1) RESPIRATORY SYNCYTIAL VIRUS - ELISA (MCE) (1) SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS (KTN) (1) REAGENT, OCCULT BLOOD (KHE) (1) ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C (GNX) (1)

Premarket Exempt

No Yes

Clear

QuickVue - 30014613201090 Catalog Number : 20109

Device Description : QkVue hCG Urine 25T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201106 Catalog Number : 20110

Device Description : QkVue HCG Combo, 50T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201120 Catalog Number : 20112

Device Description : RpdVue hCG 25T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

QuickVue+ - 30014613201212 Catalog Number : 20121

Device Description : QuickVue+ Mononucleosis 20T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 1

QuickVue+ - 30014613201229 Catalog Number : 20122

Device Description : QkVue+ Strep A, 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTZ

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201250 Catalog Number : 20125

Device Description : QkVue Strep A Dpstk 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201526 Catalog Number : 20152

Device Description : QkVue Strep A Dpstk 10T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201830 Catalog Number : 20183

Device Description : QkVue Flu A+B 25T, CE

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GNX

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201939 Catalog Number : 20193

Device Description : QkVue RSV 20T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : MCE, GQG

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201946 Catalog Number : 20194

Device Description : QuickVue iFOB 20T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

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