Identity
- Trade Name
- Pointe Ethyl Alcohol Reagent Set FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-EA0440-1L FDA UDI
- Description
- Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-EA0440-1L FDA UDI
- Primary DI / UDI-DI
- 00811727017406 FDA UDI
- 510(k) Number
- K032461 FDA UDI
- FDA Product Code
- DIC FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, kit, enzyme spectrophotometry 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
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, kit, enzyme spectrophotometry
Pointe Ethyl Alcohol Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethanol (ETOH) IVD, kit, enzyme spectrophotometry.
- Ethyl Alcohol Enzymatic Assay — Lin-Zhi International, Inc. · Class II
- Ethyl Alcohol Enzymatic Assay — Lin-Zhi International, Inc. · Class II
- Ethanol Gen2 — Roche Diagnostics Corp. · Class II
- Ethanol Gen2 — Roche Diagnostics Corp. · Class II
- Ethanol Gen.2 — Roche Diagnostics Corp. · Class II
- Pointe Ethyl Alcohol Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- POINTE SCIENTIFIC ALCOHOL — POINTE SCIENTIFIC, INC. · Class II
- POINTE SCIENTIFIC ALCOHOL — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K032461 also covers:
- Ethyl Alcohol DAU Calibrator, Calibrator #2 — Lin-Zhi International, Inc.
- 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.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI f4348475-ed52-4eb1-8966-1547a2296bf3 37 fields · synced May 30, 2026