BD FACSPresto™ 660746
GUDID 00382906607461
Cartridge (100) FACSPresto IVD
BECTON, DICKINSON AND COMPANY
CD4 cell marker IVD, kit, fluorescent immunoassay, rapid| 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 | |
| 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 |
| 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 |
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