Duns Number:460055742
Device Description: 5 x 1.7 ml LATEX REAGENT2 x 1.5 ml HIGH POSITIVE CONTROL2 x 1.5 ml LOW POSITIVE CONTROL2 x 5 x 1.7 ml LATEX REAGENT2 x 1.5 ml HIGH POSITIVE CONTROL2 x 1.5 ml LOW POSITIVE CONTROL2 x 15 ml DILUENT BUFFER45 disposable slides
Catalog Number
-
Brand Name
Rubajet 500 TESTS
Version/Model Number
300024012
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
K954920
Product Code
LQN
Product Code Name
Latex Agglutination Assay, Rubella
Public Device Record Key
84c11ae7-1bf4-4e95-8324-b8fe42a58c36
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |