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 100 mL R1, 1 x 37.5 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-EA0440-100 FDA UDI
- Description
- Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 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-EA0440-100 FDA UDI
- Primary DI / UDI-DI
- 00811727017390 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 SCIENTIFIC ALCOHOL — POINTE SCIENTIFIC, INC. · Class II
- POINTE SCIENTIFIC ALCOHOL — POINTE SCIENTIFIC, INC. · Class II
- Pointe Ethyl Alcohol Reagent Set — 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 b30355aa-76ae-4b5a-a4ef-49eeea700b09 37 fields · synced May 31, 2026