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, FLUORESCENT, POLIOVIRUS 1-3 (GOE) (10)

Premarket Exempt

Yes No

Clear

D3 - 30014613330561 Catalog Number : 01-050000

Device Description : D3 IFA Enterovirus Identification Kit

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330578 Catalog Number : 01-050000-BULK

Device Description : Enterovirus Reagent BULK 1 LITER

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330585 Catalog Number : 01-050001

Device Description : D3 Enterovirus Duo Pack

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330592 Catalog Number : 01-0550025

Device Description : EV MAB CONJUGATE

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330608 Catalog Number : 01-055005

Device Description : Enterovirus Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330615 Catalog Number : 01-055500-BULK

Device Description : ENTERO MAB REAGENT 500ML

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330622 Catalog Number : 01-056005

Device Description : Anti-Mouse Conjugate

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330639 Catalog Number : 01-056500-BULK

Device Description : Anti- Mouse Conjugate - Bulk

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330646 Catalog Number : 01-057005

Device Description : D3 DFA ENTERO 71 REAGENT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

D3 - 30014613330653 Catalog Number : 01-058005

Device Description : D3 DFA ENTERO 71/COX A16 REAGENT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : GOE

Prescription Use : Yes

Device Count : 1

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