Duns Number:039981550
Device Description: Legionella pneumophilia As Gp. 3, 2ml
Catalog Number
294777
Brand Name
NA
Version/Model Number
294777
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2018
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
LHL
Product Code Name
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Public Device Record Key
fac33beb-1796-4a84-87fd-568fa94e8ef5
Public Version Date
March 31, 2020
Public Version Number
3
DI Record Publish Date
August 10, 2017
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |