| Primary Device ID | 00859882007740 |
| NIH Device Record Key | 2927c0b7-0499-4acd-98db-5a4b07627eb6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procleix Babesia Assay |
| Version Model Number | Calibrators |
| Company DUNS | 056570085 |
| Company Name | GRIFOLS DIAGNOSTIC SOLUTIONS 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859882007740 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-28 |
| Device Publish Date | 2019-03-20 |
| 00859882007740 | The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det |
| 00859882007733 | The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det |
| 00859882007726 | The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det |
| 00859882007719 | The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det |