Duns Number:490578678
Device Description: Reagent C is a component of the CMV Brite™ Turbo kit which can be used as a permeabilizati Reagent C is a component of the CMV Brite™ Turbo kit which can be used as a permeabilization solution for peripheral blood leukocytes on slides. This product is registered as “in-vitro diagnostic use only” as a component of the CMV Brite™ Turbo kit with the FDA.
Catalog Number
VIR-CMV110 RC BDC
Brand Name
Reagent C - CMV Brite™ Turbo kit
Version/Model Number
VIR-CMV110 RA BDC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K991650
Product Code
LIN
Product Code Name
Antisera, Conjugated Fluorescent, Cytomegalovirus
Public Device Record Key
b2f5f05b-4092-4f0c-b42d-9073d6c7a1d4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 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. | 9 |