| Primary Device ID | 10850046056014 |
| NIH Device Record Key | efeebbba-83ef-43fb-8d6c-9abbd6d289c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Platelet PGDprime Reagent 1A |
| Version Model Number | P01111 |
| Company DUNS | 102312712 |
| Company Name | Verax Biomedical Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com | |
| Phone | 866-948-3729 |
| vts@veraxbiomedical.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10850046056014 [Primary] |
| MZC | System, Detection, Bacterial, For Platelet Transfusion Products |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-21 |
| Device Publish Date | 2023-04-13 |
| 10850046056021 - Platelet PGDprime Reagent 1B | 2023-04-27 Platelet PGDprime Reagent 1B required for processing platelet sample prior to testing with the Platelet PGDprime Test Device. |
| 10850046056045 - Platelet PGDprime Positive Control | 2023-04-27 Platelet PGDprime Positive Control for quality control testing of the Platelet PGDprime Test System. |
| 10850046056250 - Platelet PGDprime Sample Pipettes | 2023-04-27 Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube. |
| 10850046056243 - Platelet PGDprime Transfer Pipettes | 2023-04-27 Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device. |
| 10850046056236 - Platelet PGDprime Processing Tubes | 2023-04-27 Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime T |
| 10850046056113 - Platelet PGDprime Test, 20 devices plus disposables | 2023-04-27 Kit includes 20 Platelet PGDprime Test devices plus sample pipettes, transfer pipettes and sample processing tubes required to r |
| 10850046056120 - Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes | 2023-04-27 Platelet PGDprime Test System required disposable sample pipettes, processing tubes and transfer pipettes. 100 test kit |
| 10850046056137 - Platelet PGDprime Reagents, 100 Test | 2023-04-27 Platelet PGDprime Test Reagents required for processing the sample prior to testing with the Platelet PGDprime Test Device. 100 |