Dilution Solution 628515
GUDID 10888234400769
For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 10888234400769 |
| NIH Device Record Key | 671523b8-3f80-408c-a8a8-ad67e94f5f40 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dilution Solution |
| Version Model Number | 628515 |
| Catalog Number | 628515 |
| 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 | 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 |
| LIFECODES@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 | |
| Phone | 855-466-8267 |
| info@immucor.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234400769 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK150302
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 | 2016-09-15 |
On-Brand Devices [Dilution Solution]
| 10888234400769 | For Use with HLA-SSO Typing Kits |
| 10888234400745 | For Use with HLA-SSO Typing Kits |
| 10888234500827 | For Use with HLA-SSO Typing Kits |
Trademark Results [Dilution Solution]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DILUTION SOLUTION 76597193 not registered Dead/Abandoned |
C.B. Fleet Investment Corporation 2004-06-14 |
 DILUTION SOLUTION 75870003 not registered Dead/Abandoned |
C.B. Fleet Investment Corporation 1999-12-21 |
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