Duns Number:185067774
Device Description: Alcohol Dipstick Test Kit (25 Tests)
Catalog Number
D770-25
Brand Name
TECO DIAGNOSTICS
Version/Model Number
D770-25
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2022
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111206
Product Code
DIC
Product Code Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Public Device Record Key
928500e9-359e-4195-8812-090eb6910d46
Public Version Date
September 15, 2022
Public Version Number
1
DI Record Publish Date
September 07, 2022
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |