Identity
- Trade Name
- AllSource FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- AllSource DRUG DETECTOR, Single-Panel (THC 50), 25T/Box FDA UDI
- Model / Reference
- ALLDTHR FDA UDI
- Description
- AllSource DRUG DETECTOR, Single-Panel (THC 50), 25T/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850054867629 FDA UDI
- 510(k) Number
- K232659 FDA UDI
- FDA Product Code
- NFW FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 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
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, clinical
AllSource by Guangzhou Decheng Biotechnology Co., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232659 also covers:
- AllSource — Guangzhou Decheng Biotechnology Co., LTD
- AllSource — Guangzhou Decheng Biotechnology Co., LTD
- AllSource — Guangzhou Decheng Biotechnology Co., LTD
- AllSource — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD
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
- Guangzhou Decheng Biotechnology Co., LTD
Sources (1)
- FDA UDI 20210a21-6a04-46eb-b8aa-5beb311c2600 34 fields · synced May 31, 2026