PF4 Enhanced® - PF4 Enhanced assay is a qualitative solid phase - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) PF4 Enhanced assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies reactive with platelet factor 4 (PF4) when it is complexed to polyanionic compounds such as Polyvinyl Sulfonate (PVS). These antibodies are found in some patients undergoing heparin therapy.

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More Product Details

Catalog Number

X-HAT45

Brand Name

PF4 Enhanced®

Version/Model Number

X-HAT45

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

-

Product Code Details

Product Code

LCO

Product Code Name

Platelet Factor 4 Radioimmunoassay

Device Record Status

Public Device Record Key

da15e5c3-ccc4-4b26-befe-7ca90d42eb31

Public Version Date

December 21, 2020

Public Version Number

5

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