Duns Number:315028860
Catalog Number
08771669190
Brand Name
ONLINE DAT Cannabinoids II
Version/Model Number
08771669190
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 03, 2020
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
K030213
Product Code
LDJ
Product Code Name
Enzyme immunoassay, cannabinoids
Public Device Record Key
953f0548-c4f9-4433-8fce-60d527334d0c
Public Version Date
November 27, 2020
Public Version Number
2
DI Record Publish Date
March 05, 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 | 289 |
2 | A medical device with a moderate to high risk that requires special controls. | 760 |
3 | A medical device with high risk that requires premarket approval | 63 |
U | Unclassified | 4 |