Duns Number:329748847
Device Description: Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 in Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 in human serum.
Catalog Number
V-BBCMOK
Brand Name
Borrelia B31 ViraChip® IgM Test Kit
Version/Model Number
V-BBCMOK
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
K163695
Product Code
LSR
Product Code Name
Reagent, Borrelia Serological Reagent
Public Device Record Key
42a8be92-17cc-4b61-af8c-6ff7da60dee8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 08, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |