Duns Number:045623154
Device Description: Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Controls Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) 1 x 5 mL The Pointe Ethyl Alcohol Controls are for use as assayed quality control materials to monitor the precision of the Pointe Ethyl Alcohol Reagent Set (Ref# 60-EA0440-100/60-EA0440-1L) on a number of automated clinical chemistry analyzers.
Catalog Number
60-EA0448-5
Brand Name
Pointe Ethyl Alcohol Level 1 Control (50 mg/dL)
Version/Model Number
60-EA0448-5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K032461
Product Code
DKC
Product Code Name
Alcohol Control Materials
Public Device Record Key
fb6a5816-bac2-49b7-8e97-47aefaad2b6c
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |