| 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 |
| 04987562518654 - Automated Blood Coagulation Analyzer CS-5100 | 2025-09-19 A fully automated blood coagulation analyzer intended for in vitro diagnostic use. |
| 04987562518661 - Automated Blood Coagulation Analyzer CS-2500 | 2025-09-19 A fully automated blood coagulation analyzer intended for in vitro diagnostic use. |
| 04987562518678 - Automated Blood Coagulation Analyzer CA-600 series CA-620 | 2025-09-19 A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use |
| 04987562518685 - Automated Blood Coagulation Analyzer CA-600 series CA-660 | 2025-09-19 a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use. |
| 04987562499687 - Automated Blood Coagulation Analyzer CN-6000 | 2025-09-01 The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laborator |
| 04987562518630 - Automated Blood Coagulation Analyzer CN-6000 | 2025-09-01 The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laborator |
| 04987562488506 - UDM (Urinalysis Data Manager) | 2025-03-24 |
| 04987562508440 - XQ-520 XQ-Series Automated Hematology Analyzer | 2025-01-22 The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic |