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Carolina Liquid Chemistries Corp. Fentanyl Detection Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Carolina Liquid Chemistries Corp. Fentanyl Detection Kit FDA UDI
- Generic Name
- Fentanyl IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- CLCF065025 FDA UDI
Identifiers
- Catalog Number
- CLC065025 FDA UDI
- Primary DI / UDI-DI
- 00817302022346 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
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
Carolina Liquid Chemistries Corp. Fentanyl Detection Kit by Carolina Liquid Chemistries Corp. — Class II — FDA UDI — listed in FDA GUDID
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
- 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
Cleared under the same submission
K220046 also covers:
- Bioeasy Immunofluorescence Analyzer — Shenzhen Superbio Technology Co., Ltd.
- S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) — Shenzhen Superbio Technology Co., Ltd.
- U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) — Shenzhen Superbio Technology Co., Ltd.
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
- Carolina Liquid Chemistries Corp.
Sources (1)
- FDA UDI 369ed730-56b9-4d9d-adc4-db428d95bc8a 35 fields · synced May 30, 2026