Duns Number:328133103
Device Description: ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTI ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SCL-70 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PRFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
Catalog Number
ORG512
Brand Name
ANTI-SCI-70
Version/Model Number
ORG512
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
K962055
Product Code
LJM
Product Code Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Public Device Record Key
c46a262f-b34a-43eb-be24-3ba539152cc9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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. | 21 |