Duns Number:176458115
Device Description: Lateral flow immunoassay for the detection of Benzodiazepines (BZO) in urine
Catalog Number
-
Brand Name
AIMSCREEN BZO
Version/Model Number
42325
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
-
Product Code
JXM
Product Code Name
Enzyme Immunoassay, Benzodiazipine
Public Device Record Key
eb67e332-df77-46da-84b8-77daf284e3ee
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 04, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |