QUIDEL CORPORATION

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

ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. (GTY) (2) ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. (GTZ) (2) Single (specified) analyte controls (assayed and unassayed) (JJX) (2) Visual, pregnancy hCG, prescription use (JHI) (2) ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C (GNX) (1) ENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP) (LJC) (1)

Premarket Exempt

No Yes

Clear

QuickVue+ - 30014613001782 Catalog Number : 00178

Device Description : QkVue+ hCG S/U, 30T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

QuickVue+ - 30014613001799 Catalog Number : 00179

Device Description : QkVue+ hCG S/U, 90T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613002727 Catalog Number : 00272

Device Description : hCG Ctrl Set - Urine

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613002819 Catalog Number : 00281

Device Description : hCG Ctrl Set - Serum

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613003175 Catalog Number : 00317

Device Description : QkVue Flu Bulk 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GNX

Prescription Use : Yes

Device Count : 1

QuickVue In-Line - 30014613003434 Catalog Number : 00343

Device Description : QkVue InLine Strep A 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTZ

Prescription Use : Yes

Device Count : 1

QuickVue In-Line - 30014613003458 Catalog Number : 00345

Device Description : QkVue InLine Strep A Ctrl Set

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613003540 Catalog Number : 00354

Device Description : Strep A Liquid Ctrl

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTZ

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613200062 Catalog Number : 0B006

Device Description : QkVue Chlamydia 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : LJC

Prescription Use : Yes

Device Count : 1

QuickVue - 30014613201083 Catalog Number : 20108

Device Description : QkVue Strep A Dpstk 50T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

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