Identity
- Trade Name
- GenaCheck™ Fentanyl Urine Home-Use Test Cassette FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, control FDA UDI
- Model / Reference
- RA9-E02525 FDA UDI
Identifiers
- Catalog Number
- RA9-E02501 FDA UDI
- Primary DI / UDI-DI
- 00860008954800 FDA UDI
- 510(k) Number
- K233417 FDA UDI
- FDA Product Code
- NGL FDA UDIDJG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, control 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: Multiple drugs of abuse IVD, control
GenaCheck™ Fentanyl Urine Home-Use Test Cassette by Genabio Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233417 also covers:
- Rapid Response — BTNX Inc
- Rapid Response — BTNX 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.
- iCassette — Instant Technologies, Inc.
- 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
- Genabio Diagnostics Inc.
Sources (1)
- FDA UDI b7904151-c7f5-43b8-b4af-484b8a7d81f0 35 fields · synced May 30, 2026