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
Pointe Ethyl Alcohol Calibrator (100 mg/dL) - 60-EA0446-5
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.
Environmental Conditions
- 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: DNN
Device Name: Calibrators, Ethyl Alcohol
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
Device IdentifiersDevice Id: 00811727017413
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