BD FACSPresto™ 660746
GUDID 00382906607461
Cartridge (100) FACSPresto IVD
BECTON, DICKINSON AND COMPANY
CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)| Primary Device ID | 00382906607461 |
| NIH Device Record Key | 08f57647-1b71-4ad3-9203-0b0f38f1edf9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD FACSPresto™ |
| Version Model Number | 660746 |
| Catalog Number | 660746 |
| Company DUNS | 024230633 |
| Company Name | BECTON, DICKINSON AND COMPANY |
| 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 | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com | |
| Phone | +1(877)232-8995 |
| BDBCustomerService@bd.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 31 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382906607461 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150815
FDA Product Code
| PMG | Automated multicolor fluorescent imaging cytometric analysis system |
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 | 2017-08-30 |
On-Brand Devices [BD FACSPresto™]
| 00382906607478 | Kit Cartridge FACSPresto IVD |
| 00382906607461 | Cartridge (100) FACSPresto IVD |
| 00382906607454 | BD FACSPresto CD4 Counter |
Trademark Results [BD FACSPresto]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD FACSPRESTO 85675596 4606024 Live/Registered |
Becton, Dickinson and Company 2012-07-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.