veraxbiomedical.comSystem, Detection, Bacterial, Detection Systems For Platelet Transfusion Products
Verax Biomedical Incorporated
Verax Biomedical Incorporated
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005935106 | 3005935106 | Verax Biomedical Incorporated | 1 | N | 2026-01-01 | 2200 West Park Drive Suite 300 Westborough MA US 01581 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10850046056021 | Platelet PGDprime Reagent 1B - Platelet PGDprime Reagent 1B required for processing platelet sample prior to testing with the Platelet PGDprime Test Device. | 866-948-3729 | vts@veraxbiomedical.com |
| 10850046056045 | Platelet PGDprime Positive Control - Platelet PGDprime Positive Control for quality control testing of the Platelet PGDprime Test System. | 866-948-3729 | vts@veraxbiomedical.com |
| 10850046056069 | Platelet PGDprime Sample Pipettes - Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube. | 866-948-3729 | vts@veraxbiomedical.com |
| 10850046056076 | Platelet PGDprime Processing Tubes - Platelet PGDprime Processing Tubes are used to contain the platelet sample while processing with Reagents 1A, 1B and 2. | 866-948-3729 | vts@veraxbiomedical.com |
| 10850046056083 | Platelet PGDprime Transfer Pipettes - Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device. | 866-948-3729 | vts@veraxbiomedical.com |
| 10850046056090 | Platelet PGDprime Processing Tubes - Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime Test Device. | 866-948-3729 | vts@veraxbiomedical.com |
| 10850046056243 | Platelet PGDprime Transfer Pipettes - Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device. | 866-948-3729 | vts@veraxbiomedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission |
|---|---|---|
| 71863 | 1979283706 | BK160087 |
| 71863 | 1479767618 | |
| 71863 | 1576402540 | |
| 71863 | 1965930103 |
PMN#
Bacterial Detection Systems For Platelet Transfusion Products
Verax Biomedical Incorporated
System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products
Verax Biomedical Incorporated
System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products
Verax Biomedical Incorporated
GUDID#
Platelet PGDprime Sample Pipettes - Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube.
2023-04-19
Platelet PGDprime Processing Tubes - Platelet PGDprime Processing Tubes are used to contain the platelet sample while processing with Reagents 1A, 1B and 2.
2023-04-19
Platelet PGDprime Transfer Pipettes - Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device.
2023-04-19
Platelet PGDprime Processing Tubes - Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime Test Device.
2023-04-19
Platelet PGDprime Reagent 1B - Platelet PGDprime Reagent 1B required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
2023-04-19
Platelet PGDprime Positive Control - Platelet PGDprime Positive Control for quality control testing of the Platelet PGDprime Test System.
2023-04-19
Platelet PGDprime Sample Pipettes - Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube.
2023-04-19
Platelet PGDprime Transfer Pipettes - Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device.
2023-04-19
Platelet PGDprime Processing Tubes - Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime Test Device.
2023-04-19
Platelet PGDprime Test, 20 devices plus disposables - Kit includes 20 Platelet PGDprime Test devices plus sample pipettes, transfer pipettes and sample processing tubes required to run the Platelet PGDprime Test System.
2023-04-19
Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes - Platelet PGDprime Test System required disposable sample pipettes, processing tubes and transfer pipettes.100 test kit
2023-04-19
Platelet PGDprime Reagents, 100 Test - Platelet PGDprime Test Reagents required for processing the sample prior to testing with the Platelet PGDprime Test Device.100 test kit
2023-04-19
Platelet PGDprime Reagents, 20 Test - Platelet PGDprime Reagents required to perform the Platelet PGDprime Test System.20 test kit
2023-04-19
Platelet PGDprime Controls - Platelet PGDprime Positive and Negative Controls for quality control testing of the Platelet PGDprime Test System.
2023-04-19
Platelet PGDprime Test - Platelet PGDprime Test single device pouch
2023-04-17
Platelet PGDprime Reagent 1A - Platelet PGDprime Reagent 1A required to process the platelet sample prior to testing with the Platelet PGDprime Test Device.
2023-04-13
Platelet PGDprime Reagent 2 - Platelet PGDprime Reagent 2 required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
2023-04-13
Platelet PGDprime Negative Control - Platelet PGDprime Negative Control for quality control testing of the Platelet PGDprime Test System.
2023-04-13