LIFECODES LSA Class II 265200IVD

GUDID 10888234400349

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

IMMUCOR GTI DIAGNOSTICS, INC.

HLA class I antigen tissue typing IVD, kit, multiplex
Primary Device ID10888234400349
NIH Device Record Key8b9b3d9d-6c17-4146-bc47-03bda328e7ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFECODES LSA Class II
Version Model Number265200IVD
Catalog Number265200IVD
Company DUNS606034197
Company NameIMMUCOR GTI DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
EmailLIFECODES@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com
Phone855-466-8267
Emailinfo@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween -65 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234400349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZITest, Qualitative, For Hla, Non-Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-14
Device Publish Date2022-04-06

Devices Manufactured by IMMUCOR GTI DIAGNOSTICS, INC.

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10888234500841 - LIFECODES LifeScreen XP2023-07-19 LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class I
10888234400332 - LIFECODES LSA Class I 2022-04-14 LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient mat
10888234400349 - LIFECODES LSA Class II 2022-04-14LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
10888234400349 - LIFECODES LSA Class II 2022-04-14 LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient ma
10888234500810 - LIFECODES MATCH IT! Antibody Software v1.42022-02-28
10888234500803 - LIFECODES MATCH IT!™ DNA Software v1.32020-03-05
10888234500063 - LIFECODES® B-Screen® 2019-12-16 LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodie
10888234500094 - LIFECODES® QuikScreen® 2019-12-16 LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibod
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