| Primary Device ID | 06925912711117 |
| NIH Device Record Key | 9ae006ff-cbc1-448e-819e-b11fa72bd409 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNION Immune Analyzer |
| Version Model Number | UNION-C |
| Catalog Number | U6103 |
| Company DUNS | 420735989 |
| Company Name | Shenzhen YHLO Biotech Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06925912711117 [Primary] |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-03 |
| Device Publish Date | 2022-10-26 |
| 06925912718703 - iFlash-HCG | 2024-02-07 |
| 06925912718833 - iFlash-Anti-Beta2-Glycoprotein I | 2024-01-08 "Beta" is identical to the second letter of Greek alphabet. Because GUDID system couldn't recognize this letter, it is replaced |
| 06925912708506 - Reaction vessel | 2022-11-03 2000 pcs/box (2 bag/box, 1000 pcs/bag) |
| 06925912710424 - Chemiluminescence Immunoassay Analyzer | 2022-11-03 Type A |
| 06925912710462 - Chemiluminescence Immunoassay Analyzer | 2022-11-03 Type B |
| 06925912710509 - Chemiluminescence Immunoassay Analyzer | 2022-11-03 Type C |
| 06925912710547 - Chemiluminescence Immunoassay Analyzer | 2022-11-03 Type D |
| 06925912710578 - Chemiluminescence Immunoassay Analyzer | 2022-11-03 |