FDA UDI
In Commercial Distribution
🇺🇸 United States
Atida Marijuana (THC) Drug of Abuse Strip Test Rx
DI: 00810164510730
·
Model: U01CW-THC-US
·
ACESO LABORATORIES INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Atida Marijuana (THC) Drug of Abuse Strip Test Rx
- Primary DI
- 00810164510730
- Version / Model
- U01CW-THC-US
- Company Name
- ACESO LABORATORIES INC.
- Labeler DUNS
- 003099455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-03-23
- Public Version
- 1
- Public Version Date
- 2026-03-31
- Public Version Status
- New
- Public Device Record Key
- 605d4ddd-3c63-4944-8de5-a34f7d01909f
Device Description
50T, FDA
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | 862.3870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30519 | Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80810164510736 | GS1 | ||||
| Primary | 00810164510730 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182738 | 000 |