LIFECODES MATCH IT! Antibody Software v1.4 888627

GUDID 10888234500810

IMMUCOR GTI DIAGNOSTICS, INC.

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 10888234500810
• NIH Device Record Key: ece632f8-ef90-466f-8000-6899b59cc8f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFECODES MATCH IT! Antibody Software v1.4
• Version Model Number: 888627
• Catalog Number: 888627
• Company DUNS: 606034197
• Company Name: IMMUCOR GTI DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: LIFECODES@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com
• Phone: 855-466-8267
• Email: info@immucor.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234500810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK210572

FDA Product Code

• MZI: Test, Qualitative, For Hla, Non-Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-18

Devices Manufactured by IMMUCOR GTI DIAGNOSTICS, INC.

• 10888234500827 - Dilution Solution: 2023-07-31 For Use with HLA-SSO Typing Kits
• 10888234500841 - LIFECODES LifeScreen XP: 2023-07-19 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 v1.4: 2022-02-28
• 10888234500810 - LIFECODES MATCH IT! Antibody Software v1.4: 2022-02-28
• 10888234500803 - LIFECODES MATCH IT!™ DNA Software v1.3: 2020-03-05
• 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