LIFECODES® B-Screen® - LIFECODES B-Screen assay is a qualitative solid - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (E LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class II antigens.

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More Product Details

Catalog Number

BCSG

Brand Name

LIFECODES® B-Screen®

Version/Model Number

BCSG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK990043

Product Code Details

Product Code

KSZ

Product Code Name

System, Test, Automated Blood Grouping And Antibody

Device Record Status

Public Device Record Key

b39d5174-bb02-49ef-9a30-c8c711677d22

Public Version Date

December 16, 2019

Public Version Number

5

DI Record Publish Date

July 08, 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