LIFECODES MATCH IT!™ DNA Software v1.3 - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

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More Product Details

Catalog Number

888623

Brand Name

LIFECODES MATCH IT!™ DNA Software v1.3

Version/Model Number

888623

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

BK190439

Product Code Details

Product Code

MZI

Product Code Name

Test,Qualitative,For Hla,Non-Diagnostic

Device Record Status

Public Device Record Key

e8791124-c149-454d-84e7-5320ade4bce4

Public Version Date

March 05, 2020

Public Version Number

1

DI Record Publish Date

February 26, 2020

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