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

Antigen, cf (including cf control), herpesvirus hominis 1,2 (GQN) (6) Antisera, fluorescent, herpesvirus hominis 1,2 (GQL) (6) BLOCK, HEATING (JRG) (2) Multi-analyte controls unassayed (OHQ) (1) Single (specified) analyte controls (assayed and unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Quidel Molecular - 30014613311195 Catalog Number : M119

Device Description : QMol Trichomonas Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Quidel Molecular - 30014613311218 Catalog Number : M121

Device Description : QMol HSV 1+2/VZV Control Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312147 Catalog Number : M214

Device Description : AmpliVue Heatblock Insert

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : JRG

Prescription Use : Yes

Device Count : 1

AmpliVue - 30014613312154 Catalog Number : M215

Device Description : AmpliVue 64 Heatblock Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : JRG

Prescription Use : Yes

Device Count : 1

ELVIS - 30014613330110 Catalog Number : 00-001026

Device Description : ELVIS SOL 1, 26ML

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQL, GQN

Prescription Use : Yes

Device Count : 1

ELVIS - 30014613330127 Catalog Number : 00-001130

Device Description : ELVIS SOL 1, 130ML

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQL, GQN

Prescription Use : Yes

Device Count : 1

ELVIS - 30014613330158 Catalog Number : 00-011015

Device Description : ELVIS SOL 1, 15ML

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQL, GQN

Prescription Use : Yes

Device Count : 1

ELVIS - 30014613330165 Catalog Number : 00-011085

Device Description : ELVIS SOL 1, 85ML

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQN, GQL

Prescription Use : Yes

Device Count : 1

ELVIS - 30014613330196 Catalog Number : 00-013003.V2

Device Description : ELVIS SOL 3, 3ML

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQL, GQN

Prescription Use : Yes

Device Count : 1

ELVIS - 30014613330202 Catalog Number : 00-013012.V2

Device Description : ELVIS SOL 3, 12ML

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQL, GQN

Prescription Use : Yes

Device Count : 1

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