Identity
- Trade Name
- At Home Drug Test for Methamphetamine FDA UDI
- Generic Name
- Amphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Urine based drug testing device for Methamphetamine FDA UDI
- Model / Reference
- 9068T FDA UDI
- Description
- Urine based drug testing device for Methamphetamine FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00674033090682 FDA UDI
- FDA Product Code
- MVO FDA UDI
- GMDN Term
- Amphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U 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
Yes
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: Amphetamine-specific IVD, kit, rapid ICT, clinical
At Home Drug Test for Methamphetamine by Phamatech, Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine-specific IVD, kit, rapid ICT, clinical.
- SAFECUP II MULTIDRUG N5 — GERMAINE LABORATORIES, INC. · U
- CAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT ST327 — Carolina Liquid Chemistries Corp. · Class II
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- Amphetamine/Cocaine/Morphine Turnkey Split Cup — ASSURE TECH. (HANGZHOU) CO., LTD. · Class II
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Status DS™ 9 card — PRINCETON BIOMEDITECH CORP. · Class II
- INSTANT-VIEW Amphetamine Urine Cassette Test — Alfa Scientific Designs, Inc. · Class II
- N/M — IDUN SOLUTIONS LLC · Class II
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phamatech, Incorporated
Sources (1)
- FDA UDI e25bf51c-ea40-4100-a274-df4ab36857f6 35 fields · synced May 30, 2026