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

Multi-analyte controls unassayed (OHQ) (10)

Premarket Exempt

No Yes

Clear

D3 - 30014613338505 Catalog Number : 20-4700010

Device Description : Respiratory Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338512 Catalog Number : 20-4710010

Device Description : Influenza A Virus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338529 Catalog Number : 20-4720010

Device Description : Influenza B Virus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338536 Catalog Number : 20-4730010

Device Description : RSV Virus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338543 Catalog Number : 20-4740010

Device Description : Adenovirus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338550 Catalog Number : 20-4750010

Device Description : Parainfluenza 1 Virus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338567 Catalog Number : 20-4760010

Device Description : Parainfluenza 2 Virus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338574 Catalog Number : 20-4770010

Device Description : Parainfluenza 3 Virus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338581 Catalog Number : 20-4780010

Device Description : hMPV Virus Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338598 Catalog Number : 20-4810020

Device Description : HSV-1 Control Stock

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

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