FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (20 tests/kit)
DI: 00810038632018
·
Model: EDTH-114
·
EASY HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
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Basic Information
- Brand Name
- Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (20 tests/kit)
- Primary DI
- 00810038632018
- Version / Model
- EDTH-114
- Catalog Number
- EDTH-114-20
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-02-17
- Public Version
- 3
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- f42ee9d4-3e81-4617-9921-39ff29d93952
Device Description
20 tests per kit;THC Single Panel
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
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 |
|---|---|---|---|---|---|---|
| Package | 10810038632015 | GS1 | Carton | 36 | In Commercial Distribution | |
| Primary | 00810038632018 | GS1 | ||||
| Unit of Use | 30810038632019 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121557 | 000 |