PakPlus® - The PakPlus assay is a qualitative solid-phase - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) d The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/IIa.

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More Product Details

Catalog Number

PAKPLUS

Brand Name

PakPlus®

Version/Model Number

PAKPLUS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK140163

Product Code Details

Product Code

MYP

Product Code Name

Test,Platelet Antibody

Device Record Status

Public Device Record Key

09b752bb-a09d-4982-be75-be5f233255e7

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