PakAuto® - PakAuto assay is a qualitative solid phase enzyme - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) desig PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.

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More Product Details

Catalog Number

PAKAUTO

Brand Name

PakAuto®

Version/Model Number

PAKAUTO

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

865e14d6-d9b4-40e3-9f7f-6fabd1d931c2

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