| Primary Device ID | 00847817000447 |
| NIH Device Record Key | 63ea6b83-d8eb-4b03-a569-4547cd87504f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VARIANT II B-thalassemia |
| Version Model Number | 270-2154 |
| Catalog Number | 2702154 |
| 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 | true |
| 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 | true |
| 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 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847817000447 [Primary] |
| JPD | HEMOGLOBIN A2 QUANTITATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-23 |
| Device Publish Date | 2016-09-12 |
| 00847817012303 | VARIANT II B-thalassemia Short Program Wash/Diluent Solution |
| 00847817009914 | VARIANT II B-thalassemia Short Program Analytical Cartridge |
| 00847817009204 | VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set |
| 00847817008634 | VARIANT II B-thalassemia Short Program Elution Buffer 2 |
| 00847817008610 | VARIANT II B-thalassemia Short Program Elution Buffer 1 |
| 00847817000805 | VARIANT II B-Thalassemia Short Program Reorder Pack |
| 00847817000447 | VARIANT II B-thalassemia Short Program Reorder Pack |