| Primary Device ID | 80664369201384 |
| NIH Device Record Key | 8557963b-392f-45ee-a4d9-96effe23b23f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STROMATOLYSER-4DS |
| Version Model Number | FFS-800A |
| Company DUNS | 690664461 |
| Company Name | SYSMEX CORPORATION |
| Device Count | 3 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT FREEZE |
| Storage Environment Temperature | Between 2 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10664369201385 [Primary] |
| GS1 | 80664369201384 [Unit of Use] |
| KQC | Stains, Hematology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-14 |
| Device Publish Date | 2022-11-04 |
| 80664369201384 | Stain reagent for hematology analyzers |
| 04987562201389 | STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for d |