S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay)

FDA UDI

Class II (US FDA UDI)

by Shenzhen Superbio Technology Co., Ltd.

Identity

Trade Name: S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) FDA UDI
Generic Name: Fentanyl IVD, kit, rapid ICT, clinical FDA UDI
Model / Reference: 25 Tests/Kit FDA UDI

Identifiers

Catalog Number: SUPF065025 FDA UDI
Primary DI / UDI-DI: 06974521002239 FDA UDI
510(k) Number: K220046 FDA UDI
FDA Product Code: DJG FDA UDI
GMDN Term: Fentanyl IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3650 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

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

Yes

FDA UDI

Category: Fentanyl IVD, kit, rapid ICT, clinical

S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) by Shenzhen Superbio Technology Co., Ltd. — Class II — FDA UDI — listed in FDA…

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

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iCassette — Instant Technologies, Inc. · Class II
Alltest — Hangzhou AllTest Biotech Co., Ltd. · Class II
Alltest — Hangzhou AllTest Biotech Co., Ltd. · Class II
Rapid Response — BTNX Inc · Class II
AimScreen Fentanyl — GERMAINE LABORATORIES, INC. · Class II

Cleared under the same submission

K220046 also covers:

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: Shenzhen Superbio Technology Co., Ltd.

Sources (1)

FDA UDI 93cf802b-98eb-44dc-81f5-e772cf9aba0b 34 fields · synced May 30, 2026