Duns Number:119214195
Device Description: A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein s A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE)
Catalog Number
-
Brand Name
Detector Lex SLE
Version/Model Number
SLE-50
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DHC
Product Code Name
SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS
Public Device Record Key
abd72d83-ea7e-4fc7-9d3d-bf35e3c061c4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 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. | 5 |