ThromboType® THROMBOTYPE

GUDID 10888234500285

ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15

IMMUCOR GTI DIAGNOSTICS, INC.

Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

• Primary Device ID: 10888234500285
• NIH Device Record Key: c6ce24bf-c08c-44b8-8f34-2e0ebf4b23f1
• Commercial Distribution Discontinuation: 2018-08-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ThromboType®
• Version Model Number: THROMBOTYPE
• Catalog Number: THROMBOTYPE
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: waukeshatechsupport@immucor.co

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234500285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK050040

FDA Product Code

• MYP: Test,Platelet Antibody

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-08-15
• Device Publish Date: 2016-07-08

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
• 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