Stopping Solution - For Use with PakPlus100 - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: For Use with PakPlus100

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More Product Details

Catalog Number

404585

Brand Name

Stopping Solution

Version/Model Number

404585

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

-

Product Code Details

Product Code

MYP

Product Code Name

Test,Platelet Antibody

Device Record Status

Public Device Record Key

f71a8256-e918-4bdb-b498-71e218f49053

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 03, 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