Identity
- Trade Name
- Status Toxi Cup 13+4 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 adulterants: AMP1000 BAR300 COC300 THC50 MAD300 MET1000 MDMA500 OPI2000 OXY100 PCP25 TCA1000 BUP10 Adulterants - CRE, pH, SG, NBP FDA UDI
- Model / Reference
- 65C12+4 FDA UDI
- Description
- Status Toxi-Cup 13 panel drug cup with 4 adulterants: AMP1000 BAR300 COC300 THC50 MAD300 MET1000 MDMA500 OPI2000 OXY100 PCP25 TCA1000 BUP10 Adulterants - CRE, pH, SG, NBP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863480002113 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
- 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
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
Status Toxi Cup 13+4 by Lifesign L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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- QTEST 12 (25 Pack) — MEDIMPEX UNITED, INC
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- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
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K130275 also covers:
- Status Toxi Cup — Lifesign L.L.C.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
- QuikScreen — SYNTRON BIORESEARCH, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lifesign L.L.C.
Sources (1)
- FDA UDI e6714c35-5419-43ff-8eea-02e12413aee8 35 fields · synced Jun 6, 2026