Identity
- Trade Name
- Alco-Screen02 FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use. 510K Cleared - CliaWaived FDA UDI
- Model / Reference
- 56001 FDA UDI
- Description
- ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use. 510K Cleared - CliaWaived FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00737051863109 FDA UDI
- 510(k) Number
- K121256 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-Screen02 by Chematics, Inc. — 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
- Chematics, Inc.
Sources (1)
- FDA UDI 67095d2e-7d6a-4865-bbfb-8ccc03dc8e8d 36 fields · synced Jun 6, 2026