Identity
- Trade Name
- Personal Care FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, reagent FDA UDI
- Device Name
- Cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing.This Reagent, the Marijuana(THC) Rapid Test Cassette detects 11-nor-Delta9-THC-9-COOH in urine at concentrations equal to or greater than 50 ng/ml. The Marijuana (THC) Test is a rapid qualitative competitive binding immunoassay for determination of Marijuana in urine. FDA UDI
- Model / Reference
- Cassette FDA UDI
- Description
- Cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing.This Reagent, the Marijuana(THC) Rapid Test Cassette detects 11-nor-Delta9-THC-9-COOH in urine at concentrations equal to or greater than 50 ng/ml. The Marijuana (THC) Test is a rapid qualitative competitive binding immunoassay for determination of Marijuana in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00808829121612 FDA UDI
- FDA Product Code
- PVJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cannabinoid/cannabinoid metabolite IVD, reagent
Personal Care by Delta Brands Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Delta Brands Inc.
Sources (1)
- FDA UDI b0076ec7-a915-42e5-8e78-d0e1383ae87e 33 fields · synced May 29, 2026