Rapid Response

FDA UDI

Class II (US FDA UDI)

by BTNX Inc

Identity

Trade Name: Rapid Response FDA UDI
Generic Name: Cotinine IVD, kit, rapid ICT, clinical FDA UDI
Device Name: Rapid Response Saliva Drug Test (COT/THC) - THC40, COT30 FDA UDI
Model / Reference: D2.12-2FC1 FDA UDI
Description: Rapid Response Saliva Drug Test (COT/THC) - THC40, COT30 FDA UDI

Identifiers

Primary DI / UDI-DI: 10722066008369 FDA UDI
510(k) Number: K223162 FDA UDI
FDA Product Code: LDJ FDA UDI
MKU FDA UDI
GMDN Term: Cotinine IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3870 FDA UDI
862.3220 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cotinine IVD, kit, rapid ICT, clinical

Rapid Response by BTNX Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cotinine IVD, kit, rapid ICT, clinical.

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U-Catch — Shenzhen Bioeasy Biotechnology Co., Ltd. · Class I
UScreen Oral — Guangzhou Decheng Biotechnology Co., LTD · Class II

Cleared under the same submission

K223162 also covers:

Rapid Response — BTNX Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: BTNX Inc

Sources (1)

FDA UDI ed89b6a1-8178-43ef-9f40-96e9764e6a25 34 fields · synced May 30, 2026