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) (3) Antisera, fluorescent, human metapneumovirus (OMG) (3) ANTIGEN, CF, (INCLUDING CF CONTROL), VARICELLA-ZOSTER (GQW) (2) ANTISERUM, FLUORESCENT, CHLAMYDIA TRACHOMATIS (LJP) (2)

Premarket Exempt

Yes No

Clear

D3 Ultra - 30014613330455 Catalog Number : 01-013502.V2

Device Description : Parainfluenza 1 DFA Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330462 Catalog Number : 01-013602.V2

Device Description : Parainfluenza 2 DFA Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Ultra - 30014613330479 Catalog Number : 01-013702.V2

Device Description : Parainfluenza 3 DFA Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 - 30014613330493 Catalog Number : 01-020000

Device Description : D3 DFA Varicella-zoster Virus Kit

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQW

Prescription Use : Yes

Device Count : 1

D3 - 30014613330509 Catalog Number : 01-025005

Device Description : VZV DFA REAGENT

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQW

Prescription Use : Yes

Device Count : 1

D3 - 30014613330516 Catalog Number : 01-030000

Device Description : MPV DFA KIT

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : OMG

Prescription Use : Yes

Device Count : 1

D3 - 30014613330523 Catalog Number : 01-035002

Device Description : MPV/DFA REAGENT 2ML

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : OMG

Prescription Use : Yes

Device Count : 1

D3 - 30014613330530 Catalog Number : 01-035005

Device Description : MPV MAB CONJUGATE

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : OMG

Prescription Use : Yes

Device Count : 1

D3 - 30014613330547 Catalog Number : 01-040000

Device Description : D3 DFA CHLM CULT CONF KIT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LJP

Prescription Use : Yes

Device Count : 1

D3 - 30014613330554 Catalog Number : 01-045005

Device Description : CTMAB CONJUGATE

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LJP

Prescription Use : Yes

Device Count : 1

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