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) (3) ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS (GQG) (2) Instrumentation for clinical multiplex test systems (NSU) (1) REAGENT, BORRELIA SEROLOGICAL REAGENT (LSR) (1) Visual, pregnancy hCG, prescription use (JHI) (1) Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples (PGI) (1) ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C (GNX) (1)

Premarket Exempt

No Yes

Clear

Sofia - 30014613202424 Catalog Number : 20242

Device Description : Sofia RSV 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GQG

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202530 Catalog Number : 20253

Device Description : Sofia Strep A 25T, US

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202547 Catalog Number : 20254

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 - 30014613202608 Catalog Number : 20260

Device Description : Sofia RSV 25T, US

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GQG

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202660 Catalog Number : 20266

Device Description : Sofia hCG 50T

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202745 Catalog Number : 20274

Device Description : Sofia Strep A+ 25T, US

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202769 Catalog Number : 20276

Device Description : Sofia Strep A+ 25T

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 1

Solana - 30014613202783 Catalog Number : 20278

Device Description : Solana instrument

Device Class : 2

Duns Number: 079509836

Premarket Exempt : Yes

Product Code : NSU

Prescription Use : Yes

Device Count : 1

Sofia - 30014613202981 Catalog Number : 20298

Device Description : Sofia Lyme FIA

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Lyra - 30014613311027 Catalog Number : M102

Device Description : Lyra Direct HSV 1+2/VZV Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : PGI

Prescription Use : Yes

Device Count : 1

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