| Z-2968-2020 | Class II | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregna | August 7, 2020 |
| Z-2967-2020 | Class II | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 Th | August 7, 2020 |
| Z-2423-2020 | Class II | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | May 22, 2020 |
| Z-1420-2020 | Class II | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | January 10, 2020 |
| Z-0676-2019 | Class II | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY fo | November 30, 2018 |
| Z-0675-2019 | Class II | ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative mea | November 30, 2018 |
| Z-0671-2019 | Class II | AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measure | November 30, 2018 |
| Z-0673-2019 | Class II | ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the qu | November 30, 2018 |
| Z-0672-2019 | Class II | AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement | November 30, 2018 |
| Z-0674-2019 | Class II | ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative mea | November 30, 2018 |
| Z-0509-2019 | Class II | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 | October 5, 2018 |
| Z-0601-2019 | Class III | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision | October 5, 2018 |
| Z-0469-2019 | Class II | AIA-900 Analyzer, Product code 022930, 022930R | October 5, 2018 |
| Z-0600-2019 | Class II | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capa | September 28, 2018 |
| Z-0599-2019 | Class II | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-9 | September 28, 2018 |
| Z-0475-2019 | Class II | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of pe | September 28, 2018 |
| Z-0485-2019 | Class II | Tosoh AIA-900 immunoassay Analyzer | September 28, 2018 |
| Z-0559-2019 | Class II | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer i | August 23, 2018 |
| Z-3244-2018 | Class II | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative m | July 13, 2018 |
| Z-2745-2018 | Class II | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The To | June 6, 2018 |