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SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50) FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- DTH-101-a-Sgl FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810124273095 FDA UDI
- FDA Product Code
- LDJ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50) by Alere San Diego, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.
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- QuickProfile™ THC Test Strip — LumiQuick Diagnostics, Inc. · Class II
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
- Alere San Diego, Inc.
Sources (1)
- FDA UDI 8f7d32ad-b1ba-447a-a680-465904e7b822 32 fields · synced Jun 9, 2026