Identity
- Trade Name
- Amazewell FDA UDI
- Generic Name
- Amphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Amazewell™ D-Pen™ Oral Fluid Drug Test, 11-Panel, 25T/Box FDA UDI
- Model / Reference
- DPO-1116PA FDA UDI
- Description
- Amazewell™ D-Pen™ Oral Fluid Drug Test, 11-Panel, 25T/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850054867056 FDA UDI
- FDA Product Code
- PUX FDA UDIPUY FDA UDIPVA FDA UDIPVJ FDA UDIPVE FDA UDIPVD FDA UDIPVH FDA UDI
- GMDN Term
- Amphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3150 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3620 FDA UDI862.3610 FDA UDI862.3650 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, clinicalBarbiturate IVD, kit, rapid ICT, clinical
Amazewell by Guangzhou Decheng Biotechnology Co., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Guangzhou Decheng Biotechnology Co., LTD
Sources (1)
- FDA UDI 68359e17-e3ae-4fa8-8eb9-ec2232406f0a 33 fields · synced May 31, 2026