Duns Number:329748847
Device Description: Westernblot-assay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / Westernblot-assay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum.
Catalog Number
V-BBBMUS
Brand Name
Borrelia B31 IgM ViraBlot® Test Kit
Version/Model Number
V-BBBMUS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051169
Product Code
LSR
Product Code Name
Reagent, Borrelia Serological Reagent
Public Device Record Key
89dbd359-ae0a-48ec-8f54-743e3cea3dfe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 18, 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. | 12 |