| Primary Device ID | 00850032683043 |
| NIH Device Record Key | 1785ab82-7c80-4219-b6c3-e7cf3c4a4e15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procleix Babesia/WNV Quality Control |
| Version Model Number | Babesia/WNV Negative Control |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850032683043 [Primary] |
| QTM | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-23 |
| Device Publish Date | 2023-02-15 |
| 00850032683067 | Procleix Babesia/WNV Quality Control, a set of quality controls, is intended for use as an exter |
| 00850032683050 | Procleix Babesia/WNV Quality Control, a set of quality controls, is intended for use as an exter |
| 00850032683043 | Procleix Babesia/WNV Quality Control, a set of quality controls, is intended for use as an exter |