Identity
- Trade Name
- Status DS™ 4/MET stick FDA UDI
- Generic Name
- Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Status DS™ TH/O/C/ME stick; 35 Test kit FDA UDI
- Model / Reference
- DOA-141-35-00 FDA UDI
- Description
- Status DS™ TH/O/C/ME stick; 35 Test kit FDA UDI
Identifiers
- Catalog Number
- DOA-141-35-00 FDA UDI
- Primary DI / UDI-DI
- 10743816000334 FDA UDI
- 510(k) Number
- K992068 FDA UDI
- FDA Product Code
- DJC FDA UDIDIO FDA UDIDJG FDA UDILDJ FDA UDI
- GMDN Term
- Methamphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3610 FDA UDI862.3250 FDA UDI862.3650 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
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 DS™ 4/MET stick by Princeton Biomeditech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 033f701f-b8f1-4168-ba11-8400c15c4833 37 fields · synced Jun 1, 2026