PakAuto® PAKAUTO
GUDID 10888234500247
PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s
IMMUCOR GTI DIAGNOSTICS, INC.
Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 10888234500247 |
| NIH Device Record Key | 865e14d6-d9b4-40e3-9f7f-6fabd1d931c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PakAuto® |
| Version Model Number | PAKAUTO |
| Catalog Number | PAKAUTO |
| 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 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888234500247 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK960059
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 | 2016-07-08 |
On-Brand Devices [PakAuto®]
| 10888234500728 | PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to |
| 10888234500247 | PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to |
Trademark Results [PakAuto]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PAKAUTO 75108932 2111375 Live/Registered |
IMMUCOR GTI DIAGNOSTICS, INC. 1996-05-24 |
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