Reagent A - CMV Brite™ Turbo kit - Reagent A is a component of the CMV Brite™ Turbo - IQ Products B.V.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

LIN

Product Code Name

Antisera, Conjugated Fluorescent, Cytomegalovirus

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IQ PRODUCTS B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9