| Primary Device ID | 04987562433469 |
| NIH Device Record Key | 9112f1ce-50b3-4924-a1d7-6141e36731a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UC CONTROL |
| Version Model Number | AU448468 |
| 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)879-7644 |
| 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 |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 04987562433469 [Primary] |
| JJW | Urinalysis Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| 04987562503131 - XQ-320 XQ-Series Automated Hematology Analyzer | 2024-06-03 The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic |
| 04987562020102 - CELLPACK | 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). |
| 04987562020171 - CELLPACK | 2022-12-08 CELLPACK is a reagent for measuring the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection). |
| 04987562022090 - STROMATOLYSER-3WP | 2022-12-08 STROMATOLYSER-3WP is a lysing reagent to eliminate red blood cells and cell stroma for use in accurate determination of WBC coun |
| 04987562022335 - STROMATOLYSER-FB | 2022-12-08 STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry method, using a semiconductor l |
| 04987562200269 - STROMATOLYSER-IM | 2022-12-08 STROMATOLYSER-IM is lyse reagent for the IMI channel of Sysmex Automated Hematology Analyzers. |
| 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* |