Duns Number:276816717
Device Description: VIDAS ® TOXO Competition assay is an automated qualitative IA intended for use on VIDAS fa VIDAS ® TOXO Competition assay is an automated qualitative IA intended for use on VIDAS family instrument for the screening of total anti - Toxoplasma in human serum or plasma.
Catalog Number
-
Brand Name
VIDAS® TOXO Compétition
Version/Model Number
30211-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
-
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
LGD
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Public Device Record Key
b25f9b36-903f-4aba-b1f1-f47d598e8ecc
Public Version Date
February 02, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |