Duns Number:490578678
Device Description: Reagent A is a component of the CMV Brite™ Turbo kit which can be used in direct lysis of Reagent A is a component of the CMV Brite™ Turbo kit which can be used in direct lysis of peripheral blood erythrocytes. 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 RA BDC
Brand Name
Reagent A - 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
af8829dd-4790-46cb-9239-0b655c87f305
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 |