| Z-1105-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 S | December 21, 2022 |
| Z-1104-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material | December 21, 2022 |
| Z-1106-2023 | Class II | cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 68 | December 21, 2022 |
| Z-0097-2023 | Class II | cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) | September 8, 2022 |
| Z-0828-2022 | Class II | cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 | November 16, 2021 |
| Z-0083-2022 | Class II | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 | September 3, 2021 |
| Z-2498-2021 | Class II | cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 | August 4, 2021 |
| Z-1414-2021 | Class II | cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190 | March 25, 2021 |
| Z-1413-2021 | Class II | cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for | March 25, 2021 |
| Z-0877-2021 | Class II | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 | November 23, 2020 |
| Z-0846-2021 | Class II | The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplifi | November 19, 2020 |
| Z-2551-2020 | Class II | MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: | June 3, 2020 |
| Z-1956-2018 | Class II | MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully auto | May 2, 2018 |
| Z-1195-2018 | Class II | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic. | October 27, 2017 |
| Z-0750-2017 | Class II | LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for | November 16, 2016 |
| Z-2203-2016 | Class III | cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay. | May 17, 2016 |
| Z-2216-2016 | Class II | cobas¿ Liat¿ Analyzer | May 9, 2016 |
| Z-2254-2016 | Class II | cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 | April 5, 2016 |
| Z-1830-2016 | Class II | cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instruction | March 15, 2016 |
| Z-1578-2016 | Class II | Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems | March 3, 2016 |