LIFECODES MATCH IT! Antibody Software v1.4 - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

888627

Brand Name

LIFECODES MATCH IT! Antibody Software v1.4

Version/Model Number

888627

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

BK210572

Product Code Details

Product Code

MZI

Product Code Name

Test, Qualitative, For Hla, Non-Diagnostic

Device Record Status

Public Device Record Key

ece632f8-ef90-466f-8000-6899b59cc8f7

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 18, 2022

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