K-ASSAY® Fibrinogen Calibrator - For the calibration of the K-ASSAY® Fibrinogen - KAMIYA BIOMEDICAL COMPANY, LLC

Duns Number:197934250

Device Description: For the calibration of the K-ASSAY® Fibrinogen assay.

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More Product Details

Catalog Number

KAI-136C

Brand Name

K-ASSAY® Fibrinogen Calibrator

Version/Model Number

KAI-136C

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

K993482

Product Code Details

Product Code

GIS

Product Code Name

Test, Fibrinogen

Device Record Status

Public Device Record Key

cc12cca9-a590-4457-996a-47ca75863e1f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KAMIYA BIOMEDICAL COMPANY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 66