DIAGNOSTIC HYBRIDS, INC.

DIAGNOSTIC HYBRIDS, INC.

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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

Single (specified) analyte controls (assayed and unassayed) (JJX) (5) Multi-analyte controls unassayed (OHQ) (4) Respiratory virus panel nucleic acid assay system (OCC) (2) Human metapneumovirus (hmpv) rna assay system (OEM) (1) Influenza A and influenza B multiplex nucleic acid assay (OZE) (1) real time Nucleic acid amplification system (OOI) (1)

Premarket Exempt

No Yes

Clear

Lyra - 30014613311003 Catalog Number : M100

Device Description : Lyra FLU A+B Assay

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : OOI, OZE, OCC

Prescription Use : Yes

Device Count : 1

Lyra - 30014613311034 Catalog Number : M103

Device Description : Lyra RSV+HMPV Assay

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : OEM, OCC

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311065 Catalog Number : M106

Device Description : QMol FLUA+B Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311072 Catalog Number : M107

Device Description : QMol RSV+HMPV Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311089 Catalog Number : M108

Device Description : QMol CDIFF Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311096 Catalog Number : M109

Device Description : QMol HSV 1+2 Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311102 Catalog Number : M110

Device Description : QMol Adeno Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311157 Catalog Number : M115

Device Description : QMol Parainflu Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ, JJX

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311164 Catalog Number : M116

Device Description : QMol GBS Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311171 Catalog Number : M117

Device Description : QMol Bordetella Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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