| Seronorm® Cardiac Acute Liq L-3 | 17090041920627 | SERO AS | Unknown class | |
| Seronorm® Cardiac Acute Lyo L-1A | 17090041921815 | SERO AS | Unknown class | |
| Seronorm® Cardiac Acute Lyo L-1B | 17090041921822 | SERO AS | Unknown class | |
| Seronorm® Cardiac Acute Lyo L-2 | 17090041921839 | SERO AS | Unknown class | |
| Seronorm® Cardiac Acute Lyo L-3 | 17090041921846 | SERO AS | Unknown class | |
| SmarLumi | 06933289858373 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859776 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859783 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859790 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859806 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859813 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859820 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859837 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859844 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859851 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| SmarLumi | 06933289859868 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| sST2 Control | 06926802604533 | MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Unknown class | |
| sST2 Controls | 06975090500416 | Accucise Diagnostics Inc. | Unknown class | |
| sST2 Controls | 06975090501413 | Accucise Diagnostics Inc. | Unknown class | |
| ST2 Control | 06903053059886 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Class C | |
| ST2 Control | 06903053059893 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Class C | |
| ST2 Control | 06903053059909 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Class C | |
| ST2 Control | 06903053059916 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Class C | |
| SuperFlex CK-MB Control | 06951045810519 | Suzhou Sym-Bio Lifescience Co., Ltd. | Unknown class | |
| SuperFlex cTnI Control | 06951045810526 | Suzhou Sym-Bio Lifescience Co., Ltd. | Unknown class | |
| SuperFlex MYO Control | 06951045810571 | Suzhou Sym-Bio Lifescience Co., Ltd. | Unknown class | |
| Troponin I Control HumaFIA SR | 06976343800086 | Beijing HumaDX Tech Co., Ltd. | Unknown class | |
| VALIDATE® CM1 Test Set | 00850011135228 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® CM1 Test Set | 00859110005593 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® CM1 Test Set | 00859110005609 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® CM1 Test Set | 00859110005616 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® CM2 Test Set | 00859110005623 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® CM2 Test Set | 00859110005630 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® HS Troponin Test Set | 00850011135280 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® HS Troponin Test Set | 00859110005692 | LGC Clinical Diagnostics, Inc. | Unknown class | |