Duns Number:068288943
Device Description: VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specifi VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema Pallidum bacteria (syphilis). Kit contains 5.5 ml VDRL Antigen reagent, 60 ml of buffered diluent and product instructions.
Catalog Number
V-55
Brand Name
VDRL Antigen Kit
Version/Model Number
V-55
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
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
-
Product Code
GMQ
Product Code Name
Antigens, Nontreponemal, All
Public Device Record Key
feed8fb9-b765-4da9-ac62-de04185df9a0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 17, 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. | 6 |