DonorScreen-HLA® Class I and Class II DSI+II
GUDID 10888234500193
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. Don
IMMUCOR GTI DIAGNOSTICS, INC.
HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 10888234500193 |
| NIH Device Record Key | 8637b7ae-c477-415c-a82b-34821ca9cfb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DonorScreen-HLA® Class I and Class II |
| Version Model Number | DSI+II |
| Catalog Number | DSI+II |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.co | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com | |
| Phone | 855-466-8267 |
| info@immucor.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234500193 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK070045
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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-01 |
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 |
Trademark Results [DonorScreen-HLA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DONORSCREEN-HLA 86272299 4824864 Live/Registered |
Immucor GTI Diagnostics, Inc. 2014-05-05 |
 DONORSCREEN-HLA 77513676 3542284 Dead/Cancelled |
IMMUCOR GTI DIAGNOSTICS, INC. 2008-07-02 |
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