Identity
- Trade Name
- iCassette FDA UDI
- Generic Name
- Fentanyl IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- CLIA Waived FTY/FYL 1ng/ml Cassette FDA UDI
- Model / Reference
- ABTDFYW11201A FDA UDI
- Description
- CLIA Waived FTY/FYL 1ng/ml Cassette FDA UDI
Identifiers
- Catalog Number
- ABTDFYW11201A FDA UDI
- Primary DI / UDI-DI
- 00817405024025 FDA UDI
- 510(k) Number
- K233417 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fentanyl IVD, kit, rapid ICT, clinical
iCassette by Instant Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fentanyl IVD, kit, rapid ICT, clinical.
- S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) — Shenzhen Superbio Technology Co., Ltd. · Class II
- SAFElife™ — WONDFO USA CO., LTD. · Class II
- FIRSTVIEW Fentanyl Urine Test Cassette — Safecare Biotech (Hangzhou) Co., Ltd. · Class II
- AllTest Fentanyl Rapid Test (Urine) — Hangzhou AllTest Biotech Co., Ltd. · 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
K233417 also covers:
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- GenaCheck™ Fentanyl Urine Home-Use Test Cassette — Genabio Diagnostics Inc.
- AllTest — Hangzhou AllTest Biotech Co., Ltd.
- Alltest — Hangzhou AllTest Biotech Co., Ltd.
- Alltest — Hangzhou AllTest Biotech Co., Ltd.
- Alltest — Hangzhou AllTest Biotech Co., Ltd.
- Alltest — Hangzhou AllTest Biotech Co., Ltd.
- CLIA waived, Inc. Rapid Drug Test Device “RDTD” for Fentanyl in Urine — Hangzhou AllTest Biotech Co., Ltd.
- Discover — Hangzhou AllTest Biotech Co., Ltd.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL 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
- Instant Technologies, Inc.
Sources (1)
- FDA UDI 7d0b433e-8971-463e-a713-8d1ca57d3c8c 37 fields · synced May 30, 2026