Pointe Ethyl Alcohol Calibrator (100 Mg/dl)
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#…
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.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Eterbio, Inc. | Zhuhai | Guangdong | Manufacturer | 29 |
Record
| Listed by | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | DNN |
| Device type | Calibrators, Ethyl Alcohol |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K032461 |
| Record published | 2020-09-25 |
| Record revised | 2025-10-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-EA0446-5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Laboratories | 3 |
| DRI Negative Alcohol Calibrator | Microgenics Corporation | 2 |
| DRI 100 mg/dL Alcohol Calibrator | Microgenics Corporation | 2 |
| Urine Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 1 |
| Synchron | Beckman Coulter, Inc. | 1 |
| Ethanol Standard Kit | Verichem Laboratories, Inc. | 1 |
| Carolina Liquid Chemistries Corp.® Etha RGT. KIT BL-421 | Carolina Liquid Chemistries | 1 |
| Ethanol Standard, Level D | Verichem Laboratories, Inc. | 1 |
| Alinity | Abbott Laboratories | 1 |
| Carolina Liquid Chemistries Corp.® Etha RGT. KIT ST321 | Carolina Liquid Chemistries | 1 |
| Pointe Scientific Alcohol Standard | Horiba Instruments Incorporated | 1 |
| Carolina Liquid Chemistries Corp.® Ethyl Alcohol CC421 | Carolina Liquid Chemistries | 1 |
Showing 12 of 15. All products under Calibrators, Ethyl Alcohol
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.