Identity
- Trade Name
- Ethyl Alcohol DAU Calibrator, Calibrator #2 FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, calibrator/control FDA UDI
- Device Name
- 5mL/bottle. Concentration: 100 mg/dL of Ethanol. FDA UDI
- Model / Reference
- 0223 FDA UDI
- Description
- 5mL/bottle. Concentration: 100 mg/dL of Ethanol. FDA UDI
Identifiers
- Catalog Number
- 0223 FDA UDI
- Primary DI / UDI-DI
- B07602230 FDA UDI
- 510(k) Number
- K032461 FDA UDI
- FDA Product Code
- DNN FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, calibrator/control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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, calibrator/control
Ethyl Alcohol DAU Calibrator, Calibrator #2 by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethanol (ETOH) IVD, calibrator/control.
Cleared under the same submission
K032461 also covers:
- Ethyl Alcohol DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Ethyl Alcohol DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Ethyl Alcohol Enzymatic Assay — Lin-Zhi International, Inc.
- Ethyl Alcohol Enzymatic Assay — Lin-Zhi International, Inc.
- Pointe Ethyl Alcohol Calibrator (100 mg/dL) — POINTE SCIENTIFIC, INC.
- Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) — POINTE SCIENTIFIC, INC.
- Pointe Ethyl Alcohol Level 2 Control (300 mg/dL) — POINTE SCIENTIFIC, INC.
- Pointe Ethyl Alcohol Reagent Set — POINTE SCIENTIFIC, INC.
- Pointe Ethyl Alcohol Reagent Set — POINTE SCIENTIFIC, INC.
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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI ba84a7ac-ae2a-4cd0-85b5-e222af3b36ee 36 fields · synced Jun 9, 2026