Identity
- Trade Name
- Detectabuse FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, control FDA UDI
- Device Name
- Urine Alcohol kitbox, 2x4mL FDA UDI
- Model / Reference
- 18007536 FDA UDI
- Description
- Urine Alcohol kitbox, 2x4mL FDA UDI
Identifiers
- Catalog Number
- 18007536 FDA UDI
- Primary DI / UDI-DI
- 00810042680586 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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, control
Detectabuse by Biochemical Diagnostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethanol (ETOH) IVD, control.
- Liquichek — Bio-Rad Laboratories · Class I
- Syva® Emit® Ethyl Alcohol Low Control — Siemens Healthcare Diagnostics · Class II
- Liquichek — Bio-Rad Laboratories · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) — POINTE SCIENTIFIC, INC. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- ARCHITECT — Abbott 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biochemical Diagnostics Inc
Sources (1)
- FDA UDI dbcbb103-4fdb-44ed-9af0-32b3c0daedda 35 fields · synced Jun 6, 2026