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

CELLS, ANIMAL AND HUMAN, CULTURED (KIR) (4) Reagents, 2019-novel coronavirus nucleic acid (QJR) (3) APPLICATOR, ABSORBENT TIPPED, STERILE (KXG) (2) QUALITY CONTROL SLIDES (LJG) (1)

Premarket Exempt

No Yes

Clear

D3 Fastpoint - 30014613338727 Catalog Number : 01-124210

Device Description : L-DFA RSV/MPV Antigen Control Slides

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : Yes

Device Count : 1

Lyra - 30014613339090 Catalog Number : M120

Device Description : Lyra SARS-CoV-2 Assay

Device Class :

Duns Number: 117359612

Premarket Exempt : No

Product Code : QJR

Prescription Use : Yes

Device Count : 1

Lyra - 30014613339144 Catalog Number : M124

Device Description : SARS-CoV-2 Direct Assay

Device Class :

Duns Number: 117359612

Premarket Exempt : No

Product Code : QJR

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613339236 Catalog Number : 601

Device Description : NP Swab with Transport Tube

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613339274 Catalog Number : 91-9696

Device Description : Vero E6, MWP, 96W96F

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613339281 Catalog Number : 50-91-9696-90

Device Description : Vero E6, MWP, 96W96F 90% conf

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613339311 Catalog Number : 602

Device Description : OP Swab with Transport Tube

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613339564 Catalog Number : 84-0101

Device Description : VERO SV WITHOUT CS

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613339571 Catalog Number : 72-9624C

Device Description : Hela, MWP, 96W24F

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

Solana SARS-CoV-2 Assay - 30014613339656 Catalog Number : M313

Device Description : Solana SARS-CoV-2 Assay

Device Class :

Duns Number: 117359612

Premarket Exempt : No

Product Code : QJR

Prescription Use : Yes

Device Count : 1

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