Duns Number:790524891
Device Description: Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit
Catalog Number
GSD01-1019
Brand Name
Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit
Version/Model Number
GSD01-1019
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 30, 2018
Issuing Agency
In HIBCC
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
K113846
Product Code
LSR
Product Code Name
Reagent, Borrelia Serological Reagent
Public Device Record Key
20937b1c-0573-440e-8aee-45a6b164741b
Public Version Date
June 04, 2021
Public Version Number
5
DI Record Publish Date
September 20, 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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 25 |