Duns Number:080953946
Device Description: The ZEUS IFA Legionella pneumophila Direct Fluorescent Antibody detection reagents are des The ZEUS IFA Legionella pneumophila Direct Fluorescent Antibody detection reagents are designed for the detection of Legionella (Groups 1 – 6) bacteria in various patient specimens, and are for In Vitro diagnostic use.
Catalog Number
FA12001
Brand Name
IFA L. pneumophila Direct FA Test System
Version/Model Number
FA12001
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
-
Product Code Name
-
Public Device Record Key
4a217963-77ba-4cc7-83fc-199ee7c8f5e5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |