Identity
- Trade Name
- Alco-Screen FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- ALCO-SCREEN is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use. 510K Cleared - CliaWaived FDA UDI
- Model / Reference
- 55001 FDA UDI
- Description
- ALCO-SCREEN is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use. 510K Cleared - CliaWaived FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00737051654806 FDA UDI
- 510(k) Number
- K121247 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
Yes
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
Alco-Screen by Chematics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical.
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- Wondfo — WONDFO USA CO., LTD. · Class II
- AIMSTRIP ALCOHOL SALIVA — GERMAINE LABORATORIES, INC. · Class II
- Q.E.D. Saliva Alcohol Test A150 — OraSure Technologies, Inc. · Class II
- Mission Saliva Test Strips — ACON Laboratories, Inc. · Class II
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
- Chematics, Inc.
Sources (1)
- FDA UDI c36a90ca-157e-4e39-b099-b394d6330337 36 fields · synced Jun 8, 2026