George King A-FACT - George King A-FACT is a low abnormal fresh frozen - GEORGE KING BIO-MEDICAL, INC

Duns Number:066761271

Device Description: George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.

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More Product Details

Catalog Number

-

Brand Name

George King A-FACT

Version/Model Number

0030-1.5

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

K945855

Product Code Details

Product Code

GGN

Product Code Name

Plasma, Coagulation Control

Device Record Status

Public Device Record Key

2b4da223-240b-4fe1-af25-e7008e89dd15

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEORGE KING BIO-MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 120