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

ANTISERA, CF, INFLUENZA VIRUS A, B, C (GNW) (6) FORMULATIONS, BALANCED SALT SOLUTIONS (KIP) (2) QUALITY CONTROL SLIDES (LJG) (2)

Premarket Exempt

No Yes

Clear

D3 - 30014613330233 Catalog Number : 01-00021

Device Description : CMV Antigen Control Slide

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 - 30014613330240 Catalog Number : 01-00050

Device Description : RSV Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 - 30014613330257 Catalog Number : 01-001025

Device Description : 40X Wash Solution Concentrate

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

D3 - 30014613330271 Catalog Number : 01-002015

Device Description : Mounting Fluid (15mL) (pH 7.0-7.4)

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330288 Catalog Number : 01-010000.V2

Device Description : D3 Ultra DFA Respiratory Virus Screening and ID kit

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330295 Catalog Number : 01-010001.V2

Device Description : D3 Ultra DFA Respiratory Virus Direct Specimen Screening set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330301 Catalog Number : 01-010002.V2

Device Description : D3 Ultra DFA Respiratory Virus Shell Vial Screening Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330318 Catalog Number : 01-010003.V2

Device Description : D3 Ultra DFA RSV Reagent Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330325 Catalog Number : 01-010004.V2

Device Description : De Ultra DFA Influenza A/Influenza B Reagent Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330349 Catalog Number : 01-010006.V2

Device Description : D3 Ultra DFA Parainfluenza Reagent Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

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