Identity
- Trade Name
- Number One FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Number One 12-Panel Drug Test Cup AMP/BZO/BUP/COC/MET/MTD/MDMA/OPI/OXY/PCP/TCA/THC FDA UDI
- Model / Reference
- N1T-1126-P FDA UDI
- Description
- Number One 12-Panel Drug Test Cup AMP/BZO/BUP/COC/MET/MTD/MDMA/OPI/OXY/PCP/TCA/THC FDA UDI
Identifiers
- Catalog Number
- N1T-1126-P FDA UDI
- Primary DI / UDI-DI
- 10817038022174 FDA UDI
- 510(k) Number
- K131811 FDA UDI
- FDA Product Code
- DKZ FDA UDIDIO FDA UDILDJ FDA UDIDJC FDA UDIDJG FDA UDIJXM FDA UDIDJR FDA UDILCM FDA UDILFG FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3170 FDA UDI862.3620 FDA UDI862.3910 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
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
Number One by Ucp Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131811 also covers:
- Number 1 — DEUS VULT, LLC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Diagnostics Drug Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INC
- Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP 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 |
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Manufacturer
- Manufacturer
- Ucp Biosciences, Inc.
Sources (1)
- FDA UDI 35101552-ab6a-41c0-bdd5-620e0d76c316 37 fields · synced Jun 1, 2026