Duns Number:045361136
Device Description: Latex Agglutination Slide Test for the Detection and Quantitation of serum antinucleoprote Latex Agglutination Slide Test for the Detection and Quantitation of serum antinucleoprotein factors associated with systemic Lupus Erythematosis in Human Serum.
Catalog Number
1160-050
Brand Name
RaPET® s-LE
Version/Model Number
1160-050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2019
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
LJM
Product Code Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Public Device Record Key
f40aa357-0d8b-4b3e-b03b-b75075660706
Public Version Date
February 04, 2019
Public Version Number
3
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |