FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)
DI: 00857275007124
·
Model: IDTH-115-15P
·
IDUN SOLUTIONS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)
- Primary DI
- 00857275007124
- Version / Model
- IDTH-115-15P
- Company Name
- IDUN SOLUTIONS LLC
- Labeler DUNS
- 080651010
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-16
- Public Version
- 7
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 9de048b1-35b6-4b2e-b660-2c643c2b0fb9
- Distribution End Date
- 2022-01-01
Device Description
15 THC test dip-cards
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 |
|---|---|---|---|---|---|---|
| Primary | 00857275007124 | GS1 | ||||
| Package | 00857275007025 | GS1 | 15 THC test dipcards | 15 | Not in Commercial Distribution | 2022-01-01 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153050 | 000 |