Duns Number:305684449
Device Description: Urinary antigen test
Catalog Number
2451
Brand Name
ImmuView S. pneumoniae and L. pneumophila urinary antigen test
Version/Model Number
2451
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
GWC
Product Code Name
ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE
Public Device Record Key
2cf38c22-44d1-4bc3-b20f-f24c67828141
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
March 24, 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 | 1152 |
2 | A medical device with a moderate to high risk that requires special controls. | 272 |