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

Duns Number:606034197

Device Description: LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.

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More Product Details

Catalog Number

QS12G

Brand Name

LIFECODES® QuikScreen®

Version/Model Number

QS12G

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

BK950005

Product Code Details

Product Code

MZI

Product Code Name

Test,Qualitative,For Hla,Non-Diagnostic

Device Record Status

Public Device Record Key

ffb934eb-f6a8-41ba-afae-c294477d7e7c

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