Identity
- Trade Name
- ECO® II Cup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- DOA Single Test ECO II Cup, 25Pcs/Box, CLIA Waived COC FDA UDI
- Model / Reference
- ECOIICO-25 FDA UDI
- Description
- DOA Single Test ECO II Cup, 25Pcs/Box, CLIA Waived COC FDA UDI
Identifiers
- Catalog Number
- ECOIICO-25P FDA UDI
- Primary DI / UDI-DI
- 00841824101906 FDA UDI
- FDA Product Code
- DIO FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
ECO® II Cup by W.h.p.m. 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
- W.h.p.m. Inc.
Sources (1)
- FDA UDI 0d92389b-571d-42d6-ba9b-1541358ec466 34 fields · synced May 30, 2026