Duns Number:045623154
Device Description: For the quantitative determination of ethyl alcohol in serum or whole blood. For in vitro For the quantitative determination of ethyl alcohol in serum or whole blood. For in vitro diagnostic use only.
Catalog Number
A7504-150
Brand Name
POINTE SCIENTIFIC ALCOHOL
Version/Model Number
A7504-150
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)
-
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
K972725
Product Code
DIC
Product Code Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Public Device Record Key
08067c3b-98a3-48e7-9b3b-5f518a44480c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
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 |