| Z-2286-2018 | Class II | ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in c | April 26, 2018 |
| Z-0493-2018 | Class II | 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 | November 21, 2017 |
| Z-0494-2018 | Class II | 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400 | November 21, 2017 |
| Z-0902-2015 | Class II | ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) | November 13, 2014 |
| Z-2692-2014 | Class II | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU rea | August 11, 2014 |
| Z-1173-2014 | Class II | Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): A | February 14, 2014 |
| Z-1146-2014 | Class II | ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 a | January 20, 2014 |
| Z-0924-2014 | Class III | ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) qual | December 18, 2013 |
| Z-0904-2014 | Class II | ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control | November 21, 2013 |
| Z-2280-2013 | Class III | ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell fun | September 6, 2013 |
| Z-1141-2013 | Class II | HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Nu | March 20, 2013 |
| Z-1050-2013 | Class III | ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the | February 15, 2013 |
| Z-0632-2013 | Class II | ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent | October 10, 2012 |
| Z-0633-2013 | Class II | PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyz | October 10, 2012 |
| Z-0645-2013 | Class II | ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 | September 20, 2012 |
| Z-0429-2013 | Class III | Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and Hi | September 14, 2012 |
| Z-0289-2013 | Class III | ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 2032 | September 14, 2012 |