| Primary Device ID | 19354646000084 |
| NIH Device Record Key | 42cf12b1-ed9e-4f95-b643-df0765e305a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urine 1uL TS-SBA/MacCV TFS |
| Version Model Number | 5.1 |
| Catalog Number | AI-16054 |
| Company DUNS | 487097888 |
| Company Name | Clever Culture Systems AG |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09354646000087 [Primary] |
| GS1 | 19354646000084 [Package] Contains: 09354646000087 Package: Primary, bag [1 Units] In Commercial Distribution |
| PPU | Microbial Colony Image Assessment System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-31 |
| Device Publish Date | 2020-03-23 |
| 09354646000001 - APAS Independence | 2020-03-31 The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to |
| 19354646000084 - Urine 1uL TS-SBA/MacCV TFS | 2020-03-31This Analysis Module is one of the family of AM’s designed to process incubated plates to assist with the detection of Urinary Tract Infections. See https://cleverculturesystems.com for further information. |
| 19354646000084 - Urine 1uL TS-SBA/MacCV TFS | 2020-03-31 This Analysis Module is one of the family of AM’s designed to process incubated plates to assist with the detection of Urinary |