PakPlus® PAKPLUS100
GUDID 10888234500674
The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet
IMMUCOR GTI DIAGNOSTICS, INC.
Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent| Primary Device ID | 10888234500674 |
| NIH Device Record Key | f81ee971-391b-4415-bad7-5f9f7b998b65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PakPlus® |
| Version Model Number | PAKPLUS100 |
| Catalog Number | PAKPLUS100 |
| 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 |
| waukeshatechsupport@immucor.co | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@immucor.com | |
| Phone | 855-466-8267 |
| waukeshatechsupport@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 | 10888234500674 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK140163
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-01 |
On-Brand Devices [PakPlus®]
| 10888234500674 | The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designe |
| 10888234500254 | The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designe |
Trademark Results [PakPlus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PAKPLUS 74690962 2107634 Live/Registered |
IMMUCOR GTI DIAGNOSTICS, INC. 1995-06-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.