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

APPLICATOR, ABSORBENT TIPPED, STERILE (KXG) (10)

Premarket Exempt

No Yes

Clear

DHI Specimen Collection System - 30014613337294 Catalog Number : 404C

Device Description : UTM with Minitip FLOQSwab Set - 1mL

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337300 Catalog Number : 405C

Device Description : UTM with Regular FLOQSwab Set - 1mL

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337317 Catalog Number : 406C

Device Description : UTM with Flexible minitip FLOQSwab Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337355 Catalog Number : 410C

Device Description : UTM with Ultra Minitip FLOQSwab set - 1mL

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337362 Catalog Number : 411C

Device Description : UTM with Ultra Minitip FLOQSwab set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337386 Catalog Number : 99-08018A

Device Description : UTM with Regular Flocked Swab

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337393 Catalog Number : 99-08019A

Device Description : UTM with Flexible Minitip Flocked Swab

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337409 Catalog Number : 99-08019E

Device Description : UTM with Flexible Minitip Flocked Swab

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337416 Catalog Number : 99-08021

Device Description : UTM with Flocked Swabs(1 flexible minitip, 1 regular)

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613337423 Catalog Number : 99-08024

Device Description : UTM with Flocked Swabs (Regular)

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

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