| 1drop™ ALT | 08800075500366 | 1drop Inc. | Unknown class | |
| 1drop™ AST | 08800075500373 | 1drop Inc. | Unknown class | |
| 1drop™ Glucose | 08800075500359 | 1drop Inc. | Unknown class | |
| 1drop™ Hemo | 08800075500328 | 1drop Inc. | Unknown class | |
| 1drop™ TBIL | 08800075500380 | 1drop Inc. | Unknown class | |
| 1drop™ TC | 08800075500342 | 1drop Inc. | Unknown class | |
| 1drop™ UA | 08800075500335 | 1drop Inc. | Unknown class | |
| ACCUGENCE® | 06971404131413 | e-LinkCare Meditech Co.,Ltd. | Unknown class | |
| ACEZIN AMIGold mini Blood Glucose Monitoring System | 04719880650248 | Ace Medical Technology Co., Ltd. | Unknown class | |
| AcuteckTM Blood Glucose Control Solution | 06952804819880 | Assure Tech. (Hangzhou) Co., Ltd. | Class C | |
| AcuteckTM Blood Glucose Control Solution | 06952804819897 | Assure Tech. (Hangzhou) Co., Ltd. | Class C | |
| Aria Glucose Control Solution | 08032937233642 | Biochemical Systems International S.p.A. | Unknown class | |
| Aria Glucose Control Solution | 08032937233697 | Biochemical Systems International S.p.A. | Unknown class | |
| BeneCheck III Glucose Control Solution | 04711148330145 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck III Glucose Control Solution | 04711148330152 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck III Glucose Control Solution | 04711148330169 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck II Total Cholesterol Control Solution | 04711148330206 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck II Total Cholesterol Control Solution | 04711148330213 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Glucose Control Solution | 04711148336680 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Glucose Control Solution | 04711148336697 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Glucose Control Solution | 04711148336703 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Total Cholesterol Control Solution | 04711148336741 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Total Cholesterol Control Solution | 04711148336758 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Uric Acid Control Solution | 04711148336710 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Uric Acid Control Solution | 04711148336727 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Prime Uric Acid Control Solution | 04711148336734 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Uric Acid Control Solution | 04711148330176 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Uric Acid Control Solution | 04711148330183 | General Life Biotechnology Co., Ltd. | Class C | |
| BeneCheck Uric Acid Control Solution | 04711148330190 | General Life Biotechnology Co., Ltd. | Class C | |
| Blood Glucose Control Solution | 06934175027286 | Changsha Sinocare Inc. | Unknown class | |
| Blood Glucose Control Solution | 06934175027293 | Changsha Sinocare Inc. | Unknown class | |
| Blood Glucose Control Solution | 06935784450106 | Wuxi Biohermes Bio & Medical Technology Co., Ltd. | Unknown class | |
| Blood Glucose Control Solution | 06937339211293 | VivaChek Biotech (Hangzhou) Co., Ltd. | Unknown class | |
| Blood Glucose Control Solution | 06945040113676 | Contec Medical Systems Co., Ltd. | Class C | |
| Blood Glucose Control Solution | 06945040113683 | Contec Medical Systems Co., Ltd. | Class C | |
| Blood Glucose Control Solution | 06945040113690 | Contec Medical Systems Co., Ltd. | Class C | |
| Blood Glucose Control Solution | 06958982140075 | Abiores Technology (Beijing) Co.,Ltd. | Unknown class | |
| Blood Glucose Control Solution | 06976064467339 | Changsha Contec Yixin Biotechnology Co.,Ltd. | Class C | |
| Blood Glucose Control Solution | 06976064467346 | Changsha Contec Yixin Biotechnology Co.,Ltd. | Class C | |
| Blood Glucose Control Solution | 06976064467353 | Changsha Contec Yixin Biotechnology Co.,Ltd. | Class C | |
| Blood Glucose Control Solution Level 1 | 06934175030446 | Changsha Sinocare Inc. | Class C | |
| Blood Glucose Control Solution Level 2 | 06934175030453 | Changsha Sinocare Inc. | Class C | |
| blood glucose monitoring system | 06950715571798 | Cofoe Medical Technology Co.,Ltd. | Class C | |
| blood glucose monitoring system | 06950715571828 | Cofoe Medical Technology Co.,Ltd. | Class C | |
| Blood Glucose Monitoring System | 06939184631509 | Bioland Technology Ltd. | Class C | |
| Blood Glucose Monitoring System | 06939184631523 | Bioland Technology Ltd. | Class C | |
| careSTART™ Hb Biosensor Control | 08809446081589 | WELLS BIO, INC. | Unknown class | |
| ConfiGlu G1 Glucose Control solution 2 | 08800076701106 | GenBody Inc. | Class C | |
| ConfiGlu G1 Glucose Control solution 3 | 08800076701328 | GenBody Inc. | Class C | |
| Control Solution | 04712558769037 | Visgeneer Inc. | Unknown class | |