Duns Number:556915205
Device Description: JBAIDS IVD Influenza A & B Detection Kit
Catalog Number
JRPD-ASY-0137
Brand Name
JBAIDS
Version/Model Number
JRPD-ASY-0137
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 14, 2017
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
OCC
Product Code Name
Respiratory Virus Panel Nucleic Acid Assay System
Public Device Record Key
a061b810-0a48-4a68-8529-3df48a142989
Public Version Date
February 12, 2020
Public Version Number
4
DI Record Publish Date
September 07, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |
| U | Unclassified | 1 |