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, human metapneumovirus (OMG) (7) RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA (LKT) (7) ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4 (GQS) (4) ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 (GNY) (4) ANTISERA, HAI, INFLUENZA VIRUS A, B, C (GNS) (4) ANTISERA, CF, INFLUENZA VIRUS A, B, C (GNW) (3)

Premarket Exempt

Yes No

Clear

D3 Fastpoint - 30014613330776 Catalog Number : 01-120000.B2

Device Description : D3 FASTPOINT LDFA VIR IDKIT BX

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330783 Catalog Number : 01-120001

Device Description : FASTPOINT FLUA/B KIT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330790 Catalog Number : 01-120001.B1

Device Description : FASTPOINT FLUA/B KIT BX 1

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330806 Catalog Number : 01-120001.B2

Device Description : FASTPOINT FLUA/B KIT BX 2

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330813 Catalog Number : 01-120002

Device Description : D3 FASTPOINT RSV/MPV KIT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : OMG, LKT

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330820 Catalog Number : 01-120002.B1

Device Description : FASTPOINT RSV/MPV KIT BX 1

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LKT, OMG

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330837 Catalog Number : 01-120002.B2

Device Description : FASTPOINT RSV/MPV KIT BX 2

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LKT, OMG

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330844 Catalog Number : 01-122006

Device Description : Re-Suspension Buffer

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330851 Catalog Number : 01-123104

Device Description : L-DFA Influenza A/Influenza B Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

D3 Fastpoint - 30014613330868 Catalog Number : 01-123304

Device Description : L-DFA RSV/MPV Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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