| Primary Device ID | 14987562490216 |
| NIH Device Record Key | 05f601fa-c714-4420-9db2-9db2f68e5a2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XW QC CHECK |
| Version Model Number | BP935764 |
| Company DUNS | 690664461 |
| Company Name | SYSMEX CORPORATION |
| 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 | 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 |
| Total Volume | 2 Milliliter |
| Total Volume | 2 Milliliter |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14987562490216 [Primary] |
| JPK | Mixture, hematology quality control |
| 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 | 2018-02-13 |
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