APAS Independence With IC Chromogenic MRSA BD Analysis Module; APAS Independence With IC Chromogenic MRSA TFS/S Analysis Module
Clever Culture Systems
CLEVER CULTURE SYSTEMS LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3023339158 | 3023339158 | CLEVER CULTURE SYSTEMS LIMITED | 1 | N | 2026-01-01 | 16 Anster St Adelaide South Australia AU 5000 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 307391 | 1655824320 | K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module | QQY | 2021-10-28 |
| 307391 | 1398838661 | K183648 | APAS Independence with Urine Analysis Module | PPU | 2019-05-15 |
Product Codes Associated With Registrations#
PMN#
APAS Independence With Urine Analysis Module
Clever Culture Systems AG
GUDID#
Urine 1uL TS-SBA/MacCV TFS - This 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.
2020-03-23
APAS Independence - The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection).The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose.See https://cleverculturesystems.com for further information.
2020-03-23
Urine 1uL TS-SBA/MacCV TFS - This 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.
2020-03-23