Identity
- Trade Name
- OEM 81-13 Drug Test FDA UDI
- Generic Name
- Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC FDA UDI
- Model / Reference
- U-DOA-134 FDA UDI
- Description
- OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC FDA UDI
Identifiers
- Catalog Number
- U-DOA-134 FDA UDI
- Primary DI / UDI-DI
- 10817038022129 FDA UDI
- 510(k) Number
- K131811 FDA UDI
- FDA Product Code
- DKZ FDA UDIDIO FDA UDILDJ FDA UDI
- GMDN Term
- Amphetamine/methamphetamine group 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 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: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalAmphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test by Ucp Biosciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical.
- Healgen (Private Label) - 254 — Confirm Biosciences LLC · Class II
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- INSTANT-VIEW MDMA (XTC) Urine Cassette Test — Alfa Scientific Designs, Inc. · Class II
- Healgen (Private Label) - 1145 — Confirm Biosciences LLC · Class II
- Ritter Dental Implant System — Ritter Implants GmbH CO KG · Class II
- ITL Dental — EMERY ENTERPRISES INC. · Class II
- PreChek Multi-Drug Test Square Cup — IDUN SOLUTIONS LLC · Class II
- Healgen (Private Label) - 6125 — Confirm Biosciences LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ucp Biosciences, Inc.
Sources (1)
- FDA UDI e9b545c4-ef04-420c-9fec-9331dc428bf7 37 fields · synced Jun 8, 2026