Duns Number:080589004
Device Description: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay -500 mL Kit
Catalog Number
608OF-0500
Brand Name
Immunalysis Corporation
Version/Model Number
608OF-0500
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PJD
Product Code Name
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Public Device Record Key
ba3fe851-e5a1-4277-b6af-bdb4cf228ba2
Public Version Date
April 06, 2020
Public Version Number
3
DI Record Publish Date
April 20, 2018
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |