Identity
- Trade Name
- NOBLE FDA UDI
- Generic Name
- Amphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- NOBLE Multi-Drug Urine Test Dipcard, 9-Panel, 25T/Box FDA UDI
- Model / Reference
- NMCardA-09-37-DK FDA UDI
- Description
- NOBLE Multi-Drug Urine Test Dipcard, 9-Panel, 25T/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850065976082 FDA UDI
- 510(k) Number
- K240698 FDA UDI
- FDA Product Code
- NGM FDA UDINFT FDA UDIPTH FDA UDINGL FDA UDINFV FDA UDINFY FDA UDIPTG FDA UDINGG FDA UDIQBF FDA UDIQAW FDA UDINFW FDA UDI
- GMDN Term
- Amphetamine-specific IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3150 FDA UDI862.3650 FDA UDI862.3170 FDA UDI862.3250 FDA UDI862.3620 FDA UDI862.3610 FDA UDI862.3700 FDA UDI862.3910 FDA UDI862.3870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalOpiate/opiate metabolite IVD, kit, rapid ICT, clinicalAmphetamine-specific IVD, kit, rapid ICT, clinical
Noble by Guangzhou Decheng Biotechnology Co., LTD — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K240698 also covers:
- 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
- EZCHECK — Guangzhou Decheng Biotechnology Co., LTD
- NOBLE — Guangzhou Decheng Biotechnology Co., LTD
- NOBLE — Guangzhou Decheng Biotechnology Co., LTD
- NOBLE — Guangzhou Decheng Biotechnology Co., LTD
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Guangzhou Decheng Biotechnology Co., LTD
Sources (1)
- FDA UDI ba0b6548-b176-4b58-b612-1bdb1fa200c2 34 fields · synced May 31, 2026