DIAGNOSTIC HYBRIDS, INC.

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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

Antigen, cf (including cf control), herpesvirus hominis 1,2 (GQN) (6) ANTISERA, CONJUGATED FLUORESCENT, CYTOMEGALOVIRUS (LIN) (2) ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 (GNY) (2) ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4 (GQS) (2) Antisera, fluorescent, human metapneumovirus (OMG) (2) RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA (LKT) (2) ANTISERA, HAI, INFLUENZA VIRUS A, B, C (GNS) (2)

Premarket Exempt

Yes No

Clear

D3 - 30014613330660 Catalog Number : 01-070000

Device Description : D3 DFA Cytomegalovirus ID Kit

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : LIN

Prescription Use : Yes

Device Count : 1

D3 - 30014613330677 Catalog Number : 01-075010

Device Description : CMV IEA MAB CONJUGATE

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : LIN

Prescription Use : Yes

Device Count : 1

D3 - 30014613330684 Catalog Number : 01-080000

Device Description : D3 DFA HERPES SIMPLEX ID KIT

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQN

Prescription Use : Yes

Device Count : 1

D3 - 30014613330691 Catalog Number : 01-085005

Device Description : HSV MAB CONJUGATE

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQN

Prescription Use : Yes

Device Count : 1

D3 - 30014613330707 Catalog Number : 01-090000

Device Description : D3 DFA HSV ID AND TYPING KIT

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQN

Prescription Use : Yes

Device Count : 1

D3 - 30014613330714 Catalog Number : 01-090001

Device Description : DFA HSV TYPING REAGENT DUO PK

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQN

Prescription Use : Yes

Device Count : 1

D3 - 30014613330721 Catalog Number : 01-095005

Device Description : HSV-1 MAB CONJUGATE

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQN

Prescription Use : Yes

Device Count : 1

D3 - 30014613330738 Catalog Number : 01-096005

Device Description : HSV-2 MAB CONJUGATE

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQN

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330752 Catalog Number : 01-120000

Device Description : D3 FASTPOINT RESP VIRUS ID KIT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQS, OMG, GNS, LKT, GNY

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330769 Catalog Number : 01-120000.B1

Device Description : D3 FASTPOINT LDFA VIR IDKIT BX

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GQS, OMG, GNS, LKT, GNY

Prescription Use : Yes

Device Count : 1

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