Duns Number:114152184
Catalog Number
-
Brand Name
Q.E.D. Saliva Alcohol Test A150
Version/Model Number
60156
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
Yes
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
K894001,K894001,K894001
Product Code
DIC
Product Code Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Public Device Record Key
aa00af4a-fb3f-4f02-b005-4a9e06ae4d48
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 2016
Package DI Number
20608337150302
Quantity per Package
100
Contains DI Package
00608337150308
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |