Concentrated Wash (10X) - For Use with Factor VIII Antibody Screen, - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: For Use with Factor VIII Antibody Screen, LIFECODES B-Screen, LIFECODES QuikScreen, Pak12, For Use with Factor VIII Antibody Screen, LIFECODES B-Screen, LIFECODES QuikScreen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus

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More Product Details

Catalog Number

403622

Brand Name

Concentrated Wash (10X)

Version/Model Number

403622

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

BK960059

Product Code Details

Product Code

MYP

Product Code Name

Test,Platelet Antibody

Device Record Status

Public Device Record Key

83bccd0b-f681-4a9e-8c13-74b5ff3c743e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUCOR GTI DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 54
U Unclassified 36