LIFECODES Fluoroanalyzer 888302

GUDID 10888234401124

IMMUCOR GTI DIAGNOSTICS, INC.

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Primary Device ID10888234401124
NIH Device Record Keyea42e9e7-b956-4033-9ac4-bd8cfcf7a256
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIFECODES Fluoroanalyzer
Version Model Number888302
Catalog Number888302
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 Numbertrue
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234401124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

Devices Manufactured by IMMUCOR GTI DIAGNOSTICS, INC.

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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
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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