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

QUALITY CONTROL SLIDES (LJG) (7) Multi-analyte controls unassayed (OHQ) (2) MOUNTING MEDIA (LEB) (1)

Premarket Exempt

No Yes

Clear

D3 - 30014613338604 Catalog Number : 20-4820020

Device Description : HSV-2 Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338611 Catalog Number : 20-4900010

Device Description : CMV Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338642 Catalog Number : 01-014010

Device Description : Respiratory Virus Antigen Control Slides (8 well slide, 7 viruses, 1 negative well)

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 - 30014613338659 Catalog Number : 01-002007b

Device Description : Mounting Fluid (pH 8.0-8.4)

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LEB

Prescription Use : Yes

Device Count : 1

D3 - 30014613338666 Catalog Number : 01-00100

Device Description : HSV-1/HSV-2 Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 - 30014613338673 Catalog Number : 01-00060

Device Description : VZV Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 - 30014613338680 Catalog Number : 01-00070.v2

Device Description : hMPV Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 - 30014613338697 Catalog Number : 01-00010

Device Description : Chlamydia Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 - 30014613338703 Catalog Number : 01-00020

Device Description : CMV Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613338710 Catalog Number : 01-124110

Device Description : L-DFA Influenza A/Influenza B Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

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