CELLPACK
GUDID 04987562020171
CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
SYSMEX CORPORATION
Buffered sample diluent IVD, automated/semi-automated system| Primary Device ID | 04987562020171 |
| NIH Device Record Key | e3de793f-e3ea-44ba-bd39-05ed8d0fd1ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CELLPACK |
| Version Model Number | 88408915 |
| Company DUNS | 690664461 |
| Company Name | SYSMEX CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com | |
| Phone | +1(888)879-7644 |
| crc@sysmex.com |
Device Dimensions
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
| Total Volume | 10 Liter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04987562020171 [Primary] |
FDA Product Code
| GIF | Diluent, Blood Cell |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
On-Brand Devices [CELLPACK]
| 00664369204518 | Whole blood diluent for use in hematology analyzers |
| 00664369020101 | Whole blood diluent for use in hematology analyzers |
| 04987562020171 | CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dyna |
| 04987562020102 | CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dyna |
Trademark Results [CELLPACK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLPACK 79405424 not registered Live/Pending |
Behr Bircher Cellpack BBC AG 2024-08-21 |
 CELLPACK 79012427 3209313 Dead/Cancelled |
CELLPACK AG 2005-05-10 |
 CELLPACK 75299876 2162082 Live/Registered |
SYSMEX CORPORATION 1997-05-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.