LIFECODES Class II IDv2 for use with Luminex - LIFECODES Class II IDv2 is a bead-based - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Rea LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)

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More Product Details

Catalog Number

628223

Brand Name

LIFECODES Class II IDv2 for use with Luminex

Version/Model Number

628223

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

BK110011

Product Code Details

Product Code

MZI

Product Code Name

Test,Qualitative,For Hla,Non-Diagnostic

Device Record Status

Public Device Record Key

bf2c6dba-5b8e-459b-b895-253c245c3431

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 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