Duns Number:790524891
Device Description: Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk Pack
Catalog Number
GSD04-1022
Brand Name
Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk
Version/Model Number
GSD04-1022
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 11, 2021
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
K113847
Product Code
LSR
Product Code Name
Reagent, Borrelia Serological Reagent
Public Device Record Key
5180eb2b-e229-45eb-bb62-4ebfaa140bc7
Public Version Date
August 12, 2021
Public Version Number
5
DI Record Publish Date
July 12, 2017
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 |