| Primary Device ID | 00858352006023 |
| NIH Device Record Key | 727fc6a5-83fc-496c-8b4a-d9fe04537384 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELUclear |
| Version Model Number | H360 |
| Catalog Number | H360 |
| Company DUNS | 143647035 |
| Company Name | HEMO BIOSCIENCE INC |
| Device Count | 1 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-866-332-2835 |
| info@hemobioscience.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858352006023 [Primary] |
| KSG | Media, Potentiating For In Vitro Diagnostic Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-27 |
| 00858352006009 - Hemo-QC | 2018-03-29 Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, sem |
| 00858352006016 - C3 Control Cells | 2018-03-29 C3 Control Cells are used to confirm the reactivity of anti-C3 in Anti-human globulin. |
| 00858352006023 - ELUclear | 2018-03-29ELUclear elution kit is used to elute antibodies from intact red blood cells. |
| 00858352006023 - ELUclear | 2018-03-29 ELUclear elution kit is used to elute antibodies from intact red blood cells. |
| 00858352006122 - MQC | 2018-03-29 MQC is intended for the quality control of routine blood bank reagents when tested by tube technique. |
| 00858352006139 - MQC-CAT | 2018-03-29 MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques. |