Identity
- Trade Name
- Status Stick™ 5/MET Stick FDA UDI
- Generic Name
- Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Status Stick™ME/O/C/TH/P stick; 10 Test kit FDA UDI
- Model / Reference
- DOA-151-10-00 FDA UDI
- Description
- Status Stick™ME/O/C/TH/P stick; 10 Test kit FDA UDI
Identifiers
- Catalog Number
- DOA-151-10-00 FDA UDI
- Primary DI / UDI-DI
- 10743816001386 FDA UDI
- 510(k) Number
- K992068 FDA UDI
- FDA Product Code
- LCM FDA UDIDJC FDA UDIDKE FDA UDIDJG FDA UDIDIO FDA UDIDKZ FDA UDI
- GMDN Term
- Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3610 FDA UDI862.3870 FDA UDI862.3650 FDA UDI862.3250 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
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: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalOpiate/opiate metabolite IVD, kit, rapid ICT, clinicalMethamphetamine-specific IVD, kit, rapid ICT, clinical
Status Stick™ 5/MET Stick by Princeton Biomeditech Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phencyclidine (PCP) IVD, kit, rapid ICT, clinical.
- SAFECUP II MULTIDRUG N5 — GERMAINE LABORATORIES, INC. · U
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- N/M — IDUN SOLUTIONS LLC · Class II
- AIMSCREEN PCP — GERMAINE LABORATORIES, INC. · U
- UScreen — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Phencyclidine Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD. · U
- SAFECUP III MULTIDRUG N5 — GERMAINE LABORATORIES, INC. · Class II
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class II
Cleared under the same submission
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
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI aa24b34a-b191-464e-9fa5-0d865c641ad5 37 fields · synced May 31, 2026