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Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards) FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 15 THC test dip-cards FDA UDI
- Model / Reference
- IDTH-115-15P FDA UDI
- Description
- 15 THC test dip-cards FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857275007124 FDA UDI
- 510(k) Number
- K153050 FDA UDI
- FDA Product Code
- LDJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards) by Idun Solutions Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K153050 also covers:
- CIBIO Test — Co-Innovation Biotech Co., Ltd
- CIBIO Test — Co-Innovation Biotech Co., Ltd
- Co-innovation — Co-Innovation Biotech Co., Ltd
- co-innovation — Co-Innovation Biotech Co., Ltd
- co-innovation — Co-Innovation Biotech Co., Ltd
- co-innovation — Co-Innovation Biotech Co., Ltd
- PreChek — IDUN SOLUTIONS LLC
- PreChek — IDUN SOLUTIONS LLC
- PreChek Multi-Drug Test Square Cup — IDUN SOLUTIONS LLC
- PreKnow — IDUN SOLUTIONS LLC
- PreKnow — IDUN SOLUTIONS LLC
- PreKnow — IDUN SOLUTIONS LLC
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
- Idun Solutions Llc
Sources (1)
- FDA UDI 9de048b1-35b6-4b2e-b660-2c643c2b0fb9 35 fields · synced May 30, 2026