PIFA PLUSS® PF4 Rapid Assay - A collection of reagents and other associated - AKERS BIOSCIENCES, INC.

Duns Number:611245549

Device Description: A collection of reagents and other associated materials intended to be used for the qualit A collection of reagents and other associated materials intended to be used for the qualitative detection of total antibodies to platelet factor 4-heparin complex in a clinical specimen within a short period, relative to standard laboratory testing procedures, using PIFA PLUSS® PF4 Rapid Assay.

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More Product Details

Catalog Number

4001101

Brand Name

PIFA PLUSS® PF4 Rapid Assay

Version/Model Number

4001101

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

Yes

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

59a94c8d-76a8-44c1-bdb4-075a6fb862ec

Public Version Date

July 05, 2018

Public Version Number

1

DI Record Publish Date

June 04, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-