LIFECODES LSA Class I - LIFECODES LSA Class I is a bead-based Immunoassay - IMMUCOR GTI DIAGNOSTICS, INC.

Duns Number:606034197

Device Description: LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG ant LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.

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More Product Details

Catalog Number

265100IVD

Brand Name

LIFECODES LSA Class I

Version/Model Number

265100IVD

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

BK210573

Product Code Details

Product Code

MZI

Product Code Name

Test, Qualitative, For Hla, Non-Diagnostic

Device Record Status

Public Device Record Key

3a2dc0ca-15fe-41d2-bc2e-62b97e474864

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 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