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Rhinostics, Inc.

FDA UDI

Class I (US FDA UDI)

by Rhinostics Inc

Identity

Trade Name
Rhinostics, Inc. FDA UDI
Generic Name
General specimen collection kit IVD, home-use FDA UDI
Device Name
RHINOstic® Automated Swab Kit FDA UDI
Model / Reference
LV-2D1D003 FDA UDI
Description
RHINOstic® Automated Swab Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00850042963081 FDA UDI
FDA Product Code
KXG FDA UDI
GMDN Term
General specimen collection kit IVD, home-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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 swabGeneral specimen collection kit IVD, home-use

Rhinostics, Inc. by Rhinostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen collection kit IVD, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhinostics Inc

Sources (1)

  • FDA UDI cfe2fdca-2f52-4bce-a2b9-702b29d23f98 33 fields · synced May 30, 2026