Duns Number:276816717
Device Description: VIDAS Lyme IgM II assay is an automated qualitative enzyme immunoassay intended for use on VIDAS Lyme IgM II assay is an automated qualitative enzyme immunoassay intended for use on VIDAS family instrument for detection of human IgM antibodies to Borrelia burgdorferi.
Catalog Number
-
Brand Name
VIDAS® Lyme IgM II
Version/Model Number
416436
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
-
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
K122979
Product Code
LSR
Product Code Name
Reagent, Borrelia Serological Reagent
Public Device Record Key
ab465312-4012-4bc7-960d-c47c1ba52bf1
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 |
|---|---|---|
| 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 |