LIFECODES HLA-A SSO Typing Kit - DNA Typing of Class I HLA alleles, to aid in - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and rec DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching

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More Product Details

Catalog Number

628911

Brand Name

LIFECODES HLA-A SSO Typing Kit

Version/Model Number

628911

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

BK130075

Product Code Details

Product Code

MZI

Product Code Name

Test,Qualitative,For Hla,Non-Diagnostic

Device Record Status

Public Device Record Key

e19958af-5317-41bd-ada9-8cea1b2ace7d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

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