| Primary Device ID | 14987562460370 |
| NIH Device Record Key | 19107cc3-45b1-4f47-b54f-8d5a53f98303 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCS-1000 Calibrator |
| Version Model Number | 217685 |
| 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 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14987562460370 [Primary] |
| KSA | CALIBRATOR FOR RED-CELL AND WHITE-CELL COUNTING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-18 |
| Device Publish Date | 2016-08-04 |
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| 04987562201389 - STROMATOLYSER-4DS | 2022-12-08 STROMATOLYSER-4DS is to be used to stain the leukocytes in diluted and lysed blood samples for determination of the 4-part diffe |
| 04987562201402 - STROMATOLYSER-4DL | 2022-12-08 The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* |
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