| Primary Device ID | 00859882007368 |
| NIH Device Record Key | 664a478e-dc56-4783-a7eb-6cd09e887d8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Procleix Tigris Lower Bay Fluids |
| Version Model Number | Procleix Auto Detect Reagent Kit |
| 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 | 00859882007368 [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 | 2018-09-03 |
| Device Publish Date | 2018-08-03 |
| 00859882007399 | A collection of reagents and other associated materials intended to be used to optimize an assay |
| 00859882007382 | A collection of reagents and other associated materials intended to be used to optimize an assay |
| 00859882007375 | A collection of reagents and other associated materials intended to be used to optimize an assay |
| 00859882007368 | A collection of reagents and other associated materials intended to be used to generate a chemil |