MQC-CAT - MQC-CAT is intended for the quality control of - HEMO BIOSCIENCE INC

Duns Number:143647035

Device Description: MQC-CAT is intended for the quality control of routine blood bank reagents when tested by MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques.

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More Product Details

Catalog Number

-

Brand Name

MQC-CAT

Version/Model Number

H9350

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

KSF

Product Code Name

Kit, Quality Control For Blood Banking Reagents

Device Record Status

Public Device Record Key

3212a7ef-a5f4-4563-ac2c-0db5d51ac962

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEMO BIOSCIENCE INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5