| Primary Device ID | 00382903378586 |
| NIH Device Record Key | eb57c55c-e64d-4b99-9745-a2b853d48f83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD FACSCount™ |
| Version Model Number | 337858 |
| Catalog Number | 337858 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382903378586 [Primary] |
| GKZ | Counter, differential cell |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-08 |
| 00382903446193 | BD FACSCount System Users Guide and Software |
| 00382903401673 | BD FACSCount Reagent Kit 50 Tests IVD |
| 00382903401666 | BD FACSCount Control Kit 25 Tests IVD |
| 00382903390113 | FACSCount CD4 Users Guide and Software |
| 00382903390106 | BD FACSCount CD4 Reagent Kit 50 Tests |
| 00382903378586 | BD FACSCount Instrument System |