Identity
- Trade Name
- Wondfo FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- 10-Strips; Alcohol Saliva Test Box 10 Pcs FDA UDI
- Model / Reference
- W53-S-10BX FDA UDI
- Description
- 10-Strips; Alcohol Saliva Test Box 10 Pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816862024531 FDA UDI
- FDA Product Code
- DIC FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3040 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical
Wondfo by Wondfo Usa Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical.
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- Q.E.D. Saliva Alcohol Test A150 — OraSure Technologies, Inc. · Class II
- Mission Saliva Test Strips — ACON Laboratories, Inc. · Class II
- Alco-Screen — Chematics, Inc. · Class II
- Accutest Breath Alcohol Detector — JANT PHARMACAL CORP. · Class I
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
- Wondfo Usa Co., Ltd.
Sources (1)
- FDA UDI eb588557-76ad-4ab7-87e3-f17f67f4eca1 35 fields · synced May 31, 2026