| Primary Device ID | 00847817007064 |
| NIH Device Record Key | 62c40989-f315-42e4-9148-16e34dd59e78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemoglobin Variants System |
| Version Model Number | 250-0002 |
| Catalog Number | 2500002 |
| Company DUNS | 132528295 |
| Company Name | BIO-RAD LABORATORIES, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847817007064 [Primary] |
| GKA | ABNORMAL HEMOGLOBIN QUANTITATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-02 |
| Device Publish Date | 2020-06-24 |
| 00847817007187 | Hemoglobin Variants System Control Set |
| 00847817007170 | Hemoglobin Variants System Calibrator Set |
| 00847817007156 | Hemoglobin Variants System Reorder Pack |
| 00847817007071 | Hemoglobin Variants System Wash Solution |
| 00847817007064 | Hemoglobin Variants System Elution Buffer 2 |
| 00847817007057 | Hemoglobin Variants System Elution Buffer 1 |
| 00847817006791 | Hemoglobin Variants System Cation Exchange Mini-Columns |
| 00847817007163 | Hemoglobin Variants System Cation Exchange Mini-Columns |