Identity
- Trade Name
- Pointe Ethyl Alcohol Calibrator (100 mg/dL) FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, reagent FDA UDI
- Device Name
- Pointe Ethyl Alcohol Calibrator (100 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Calibrators are for use as calibrators in the quantitation of the Pointe Ethyl Alcohol Reagent Set (Ref# 60-EA0440-100/60-EA0440-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-EA0446-5 FDA UDI
- Description
- Pointe Ethyl Alcohol Calibrator (100 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Calibrators are for use as calibrators in the quantitation of the Pointe Ethyl Alcohol Reagent Set (Ref# 60-EA0440-100/60-EA0440-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-EA0446-5 FDA UDI
- Primary DI / UDI-DI
- 00811727017413 FDA UDI
- 510(k) Number
- K032461 FDA UDI
- FDA Product Code
- DNN FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, reagent 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, reagent
Pointe Ethyl Alcohol Calibrator (100 mg/dL) by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ethanol (ETOH) IVD, reagent.
- Epredia — Richard-Allan Scientific LLC · Class I
- EtOH — Randox Laboratories, Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · 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 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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 9eadae87-b696-462c-878c-23fe23ff6b85 37 fields · synced Jun 1, 2026