Identity
- Trade Name
- High Sensitivity FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- One Step Drug Screen Test Card (COC150/AMP300/mAMP500/THC50/MOP300/OXY100/PPX300/PCP25) FDA UDI
- Model / Reference
- DOA-184-271T FDA UDI
- Description
- One Step Drug Screen Test Card (COC150/AMP300/mAMP500/THC50/MOP300/OXY100/PPX300/PCP25) FDA UDI
Identifiers
- Catalog Number
- 4580320099 FDA UDI
- Primary DI / UDI-DI
- 10815845020826 FDA UDI
- FDA Product Code
- LDJ FDA UDILCM FDA UDIJXN FDA UDIDKZ FDA UDIDJG FDA UDIDJC FDA UDIDIO 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 UDI862.3700 FDA UDI862.3100 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 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
No
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
High Sensitivity by Alere San Diego, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 bb171e6a-51cf-432a-a704-24a881e96be2 34 fields · synced Jun 9, 2026