| Primary Device ID | 05060446290040 |
| NIH Device Record Key | fe3e6cfe-dce6-4d05-8c8b-9445af102072 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microgen Legionella |
| Version Model Number | M45CE |
| Company DUNS | 231128802 |
| Company Name | MICROGEN BIOPRODUCTS LIMITED |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060446290040 [Primary] |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-06-30 |
| 05060446290019 - Salmonella Latex Kit | 2018-03-29 |
| 05060446290040 - Microgen Legionella | 2018-03-29 |
| 05060446290040 - Microgen Legionella | 2018-03-29 |
| 05060446290217 - M45a Test Reagent 1 | 2018-03-29 |
| 05060446290224 - M45b Test Reagent 2-15 | 2018-03-29 |
| 05060446290231 - M45c Positive Control | 2018-03-29 |
| 05060446290248 - M45d Test Reagent Species | 2018-03-29 |