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

C.Difficile toxin gene amplification assay (OZN) (2) Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system (PGX) (2) Nucleic acid amplification assay system, group b streptococcus, direct specimen test (NJR) (1) Parainfluenza multiplex nucleic acid assay (OOU) (1) Respiratory virus panel nucleic acid assay system (OCC) (1) Trichomonas vaginalis nucleic acid amplification test system (OUY) (1) Bordetella pertussis dna assay system (OZZ) (1) real time Nucleic acid amplification system (OOI) (1) Herpes simplex virus nucleic acid amplification assay (OQO) (1)

Premarket Exempt

No Yes

Clear

Lyra - 30014613311058 Catalog Number : M105

Device Description : Lyra Direct CDIFF Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : OZN, OOI

Prescription Use : Yes

Device Count : 1

Lyra - 30014613311126 Catalog Number : M112

Device Description : Lyra Direct Strep Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : PGX

Prescription Use : Yes

Device Count : 1

Lyra - 30014613311133 Catalog Number : M113

Device Description : Lyra Adenovirus Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : OCC

Prescription Use : Yes

Device Count : 1

Lyra - 30014613311140 Catalog Number : M114

Device Description : Lyra Parainfluenza Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : OOU

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312017 Catalog Number : M201

Device Description : AmpliVue CDiff Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : OZN

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312024 Catalog Number : M202

Device Description : AmpliVue GBS Assay

Device Class : 1

Duns Number: 079509836

Premarket Exempt : No

Product Code : NJR

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312093 Catalog Number : M209

Device Description : AmpliVue Bordetella Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : OZZ

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312109 Catalog Number : M210

Device Description : AmpliVue HSV 1+2 Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : OQO

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312116 Catalog Number : M211

Device Description : AmpliVue Trichomonas Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : OUY

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312123 Catalog Number : M212

Device Description : AmpliVue GAS Assay

Device Class : 2

Duns Number: 079509836

Premarket Exempt : No

Product Code : PGX

Prescription Use : Yes

Device Count : 1

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