The Randox Ethanol Calibrator and Control Set is intended for the calibration and quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum.
EtOH CAL/CONTROL - DA2703
Device Description
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.
Environmental Conditions
- The Ethanol Calibrators and Controls are stable for 28 days at +2°C to +8°C.
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DLJ
Device Name: Calibrators, Drug Specific
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.3200
Third Party Flag: N
Medical Specialty: TX
Code: LAS
Device Name: Drug Specific Control Materials
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.3280
Third Party Flag: N
Medical Specialty: TX
Device IdentifiersDevice Id: 05055273207873
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A