CELL-DYN 09H5901
GUDID 00380740020286
CELL-DYN EMERALD 22
ABBOTT LABORATORIES
Haematological cell analyser IVD, automated| Primary Device ID | 00380740020286 |
| NIH Device Record Key | 26cb02da-6d1d-4b1e-8864-c0aad2388692 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CELL-DYN |
| Version Model Number | 09H5901 |
| Catalog Number | 09H5901 |
| Company DUNS | 079226220 |
| Company Name | ABBOTT LABORATORIES |
| 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 | false |
| Expiration Date | false |
| 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)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx | |
| Phone | +1(877)422-2688 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00380740020286 [Primary] |
FDA Product Code
| GKZ | Counter, differential cell |
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 | 2019-12-23 |
| Device Publish Date | 2016-09-09 |
On-Brand Devices [CELL-DYN]
| 00380740020996 | CELL-DYN 1800 System DETERGENT |
| 00380740001148 | CELL-DYN Sapphire System WBC REAGENT - PART B |
| 00380740001131 | CELL-DYN Sapphire System WBC REAGENT - PART A |
| 00380740120788 | CELL-DYN Emerald 22 Diluent |
| 00380740120771 | CELL-DYN Emerald 22 Lyse |
| 00380740120764 | CELL-DYN Emerald 22 Easy Cleaner |
| 00380740119843 | CELL-DYN 22 Plus Calibrator |
| 00380740119836 | CELL-DYN 22 Plus Control |
| 00380740119829 | CELL-DYN 22 Plus Control |
| 00380740099916 | CELL-DYN Ruby |
| 00380740072643 | CELL-DYN 1800 System CN-FREE DIFF LYSE |
| 00380740072445 | CELL-DYN 1800 System DILUENT |
| 00380740071141 | CELL-DYN 1800 |
| 00380740021085 | ENZYM CLNR 2X50 ML |
| 00380740021016 | CELL-DYN 3700 System HGB / WIC LYSE |
| 00380740020989 | CELL-DYN 3700 System DETERGENT |
| 00380740020972 | CELL-DYN 1800 System DETERGENT |
| 00380740020965 | CELL-DYN 3700 SHEATH |
| 00380740020958 | CELL-DYN 3700 System DILUENT |
| 00380740020941 | CELL-DYN 1800 System DILUENT |
| 00380740020347 | CELL-DYN 18 PLUS CALIBRATOR |
| 00380740020330 | CELL-DYN 18 PLUS CONTROL |
| 00380740020323 | CELL-DYN 18 PLUS CONTROL |
| 00380740020286 | CELL-DYN EMERALD 22 |
| 00380740020156 | CELL-DYN Emerald DILUENT |
| 00380740020149 | CELL-DYN Emerald CN-FREE LYSE |
| 00380740020132 | CELL-DYN Emerald CLEANER |
| 00380740020088 | CELL-DYN Emerald |
| 00380740017170 | CELL-DYN Ruby |
| 00380740017149 | CELL-DYN RETIC PLUS CONTROL |
| 00380740017118 | CELL-DYN 26 PLUS CONTROL |
| 00380740017101 | CELL-DYN 26 PLUS CONTROL |
| 00380740017095 | CELL-DYN 29 PLUS CONTROL (with Retic) |
| 00380740017088 | CELL-DYN 29 PLUS CONTROL (with Retic) |
| 00380740017071 | CELL-DYN HemCal Plus Calibrator |
| 00380740017026 | CELL-DYN Ruby, CELL-DYN 3200 Systems WBC LYSE |
| 00380740016623 | CELL-DYN Sapphire |
| 00380740016616 | CELL-DYN Sapphire |
| 00380740013547 | CELL-DYN 1800 System CN-FREE DIFF LYSE |
| 00380740013493 | CELL-DYN 1800 |
| 00380740013356 | CELL-DYN Immuno T-Cell (CD3/4/8) Reagents |
| 00380740007317 | CELL-DYN 3200 |
| 00380740007300 | CELL-DYN 3200 |
| 00380740007270 | CELL-DYN 3200 |
| 00380740007263 | CELL-DYN 3200 |
| 00380740005160 | CELL-DYN Ruby, CELL-DYN 3200 System CN-FREE HGB/NOC LYSE |
| 00380740005153 | CELL-DYN 3200 System DILUENT/SHEATH |
| 00380740005146 | CELL-DYN 3200 WBC LYSE |
| 00380740005115 | CELL-DYN 3700 System CN-FREE HGB / WIC LYSE |
| 00380740005009 | CELL-DYN RETICULOCYTE REAGENT |
Trademark Results [CELL-DYN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELL-DYN 73387624 1298458 Live/Registered |
Sequoia-Turner Corporation 1982-09-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.