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DHI Specimen Collection System

FDA UDI

Class I (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
DHI Specimen Collection System FDA UDI
Generic Name
Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI
Device Name
UTM with Minitip FLOQSwab Set - 1mL FDA UDI
Model / Reference
404C FDA UDI
Description
UTM with Minitip FLOQSwab Set - 1mL FDA UDI

Identifiers

Catalog Number
404C FDA UDI
Primary DI / UDI-DI
30014613337294 FDA UDI
FDA Product Code
KXG FDA UDI
GMDN Term
Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oral/upper respiratory tract specimen collection kit IVD, clinical

DHI Specimen Collection System by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/upper respiratory tract specimen collection kit IVD, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA UDI 1cfb3386-3dba-43de-babe-5ae1464b32f3 35 fields · synced Jun 8, 2026