Identity
- Trade Name
- THC CONTROL 2 FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, control FDA UDI
- Device Name
- The Randox Cannabinoid Control - Level 2 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 2 contains the specific drug Cannabinoid. FDA UDI
- Model / Reference
- DA3128 FDA UDI
- Description
- The Randox Cannabinoid Control - Level 2 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 2 contains the specific drug Cannabinoid. FDA UDI
Identifiers
- Catalog Number
- DA3128 FDA UDI
- Primary DI / UDI-DI
- 05055273207965 FDA UDI
- 510(k) Number
- K092269 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Cannabinoid/cannabinoid metabolite IVD, control
Thc Control 2 by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannabinoid/cannabinoid metabolite IVD, control.
- Oral Fluid Cannabinoid Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- THC COOH HYDROLYSIS QC — UTAK LABORATORIES, INC. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Pointe Cannabinoids (THC) Control (62.5 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Cannabinoids DAU Control, Control — Lin-Zhi International, Inc. · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Cannabinoids DAU Calibrator/Control, Calibrator/Control — Lin-Zhi International, Inc. · Class I
Cleared under the same submission
K092269 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 4cc49efb-c888-45f3-b7f3-7da1011aa82f 37 fields · synced May 30, 2026