Identity
- Trade Name
- Status Toxi Cup FDA UDI
- Generic Name
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
- Device Name
- Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, TCA 1000, THC 50 + pH/CRE/NBP/SG FDA UDI
- Model / Reference
- 65C13+4 FDA UDI
- Description
- Status Toxi-Cup 13 panel drug cup with 4 adulterations - AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, TCA 1000, THC 50 + pH/CRE/NBP/SG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868348000256 FDA UDI
- FDA Product Code
- LFH FDA UDILCM FDA UDIDJG FDA UDIDJC FDA UDIDIO FDA UDILDJ FDA UDIJXM FDA UDIDIS FDA UDIDKZ FDA UDI
- GMDN Term
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3170 FDA UDI862.3150 FDA UDI862.3100 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
No
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: Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Status Toxi Cup by Lifesign L.L.C. — 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
- Lifesign L.L.C.
Sources (1)
- FDA UDI fb7293dd-529f-49dc-9aa0-c281ece12057 34 fields · synced May 30, 2026