LIFECODES MATCH IT!™ DNA Software v1.3 888623

GUDID 10888234500803

IMMUCOR GTI DIAGNOSTICS, INC.

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT) Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD
Primary Device ID10888234500803
NIH Device Record Keye8791124-c149-454d-84e7-5320ade4bce4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFECODES MATCH IT!™ DNA Software v1.3
Version Model Number888623
Catalog Number888623
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234500803 [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 Date2020-03-05
Device Publish Date2020-02-26

Devices Manufactured by IMMUCOR GTI DIAGNOSTICS, INC.

10888234500827 - Dilution Solution2023-07-31 For Use with HLA-SSO Typing Kits
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 2022-04-14 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
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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