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) APPLICATOR, ABSORBENT TIPPED, STERILE (KXG) (2) Multi-analyte controls unassayed (OHQ) (2) SYSTEM, TEST, THYROID AUTOANTIBODY (JZO) (2)

Premarket Exempt

No Yes

Clear

DHI Specimen Collection System - 30014613337430 Catalog Number : 303CHL

Device Description : UTM with Mattress Swab Set

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

DHI Specimen Collection System - 30014613338055 Catalog Number : 99-08025

Device Description : U. Minitip & Std Flock w/ 1mL

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KXG

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613338260 Catalog Number : 83-T225DH

Device Description : MDCK FLASK 225 SQ CM

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613338307 Catalog Number : 49-T225DH

Device Description : RHMK FLK 225

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

Thyretain - 30014613338383 Catalog Number : 40-100100

Device Description : GROWTH MEDIUM

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : JZO

Prescription Use : Yes

Device Count : 1

Thyretain - 30014613338390 Catalog Number : 40-300200

Device Description : Reaction Buffer

Device Class : 2

Duns Number: 117359612

Premarket Exempt : No

Product Code : JZO

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613338413 Catalog Number : 53-T225

Device Description : BGMK FLK 225 SQ CM

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

Fresh Cells - 30014613338420 Catalog Number : 70-T225

Device Description : Super-BGMK FLK 225 SQ CM

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIR

Prescription Use : Yes

Device Count : 1

D3 - 30014613338482 Catalog Number : 20-4310010

Device Description : Chlamydia trachomatis, LGV Strain

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

D3 - 30014613338499 Catalog Number : 20-4600010

Device Description : VZV Control Stock (Single Use) (shipped frozen)

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

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