FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Multi-Drug Screen Test (10 tests kit)
DI: 00855944007000
·
Model: EDOAP-564
·
EASY HEALTHCARE CORPORATION
Product Codes
5
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Easy@Home Multi-Drug Screen Test (10 tests kit)
- Primary DI
- 00855944007000
- Version / Model
- EDOAP-564
- Catalog Number
- EDOAP-564-10
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-07-01
- Public Version
- 7
- Public Version Date
- 2022-07-25
- Public Version Status
- Update
- Public Device Record Key
- 1863f81d-6ef1-4f0f-901b-e78bc552a779
Device Description
10 tests kit; 6-Panel Dip Card; THC/COC/OPI/OXY/MET/BZO
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 |
|---|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | 862.3170 | 2 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse 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 multiple drugs of abuse 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 | 10855944007007 | GS1 | Carton | 60 | In Commercial Distribution | |
| Primary | 00855944007000 | GS1 | ||||
| Unit of Use | 30855944007001 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133968 | 000 |