| Z-1702-2024 | Class II | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | March 1, 2024 |
| Z-1508-2022 | Class II | The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure tota | June 24, 2022 |
| Z-2475-2019 | Class II | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes o | February 15, 2019 |
| Z-0418-2018 | Class II | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouch | November 14, 2017 |
| Z-0588-2017 | Class II | Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Tota | October 12, 2016 |
| Z-2778-2016 | Class III | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam inse | August 2, 2016 |
| Z-2360-2016 | Class I | Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Al | July 11, 2016 |
| Z-2354-2016 | Class I | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ | July 11, 2016 |
| Z-2359-2016 | Class I | Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 | July 11, 2016 |
| Z-2361-2016 | Class I | Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRa | July 11, 2016 |
| Z-2356-2016 | Class I | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring sys | July 11, 2016 |
| Z-2358-2016 | Class I | Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Aler | July 11, 2016 |
| Z-2355-2016 | Class I | INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRat | July 11, 2016 |
| Z-2362-2016 | Class I | Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G | July 11, 2016 |
| Z-2357-2016 | Class I | Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRa | July 11, 2016 |
| Z-2269-2016 | Class III | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract | June 22, 2016 |
| Z-2265-2016 | Class III | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rap | June 22, 2016 |
| Z-2268-2016 | Class III | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an e | June 22, 2016 |
| Z-2270-2016 | Class III | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an e | June 22, 2016 |
| Z-2271-2016 | Class III | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an ext | June 22, 2016 |