| AllDx | 06978467910214 | Hangzhou Aokai Biotech Co., Ltd. | Unknown class | |
| CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution | 08800065170203 | GC MEDIS Corp. | Unknown class | |
| CERA-CHEK™ Hb Plus Hemoglobin Control Solution | 08800065170005 | GC MEDIS Corp. | Unknown class | |
| DiaSpect Control Pack HBT1 | 14048534002414 | EKF-diagnostic GmbH | Class B | |
| DiaSpect Control Pack HBT2 | 14048534002421 | EKF-diagnostic GmbH | Class B | |
| DiaSpect Control Pack HBT3 | 14048534002438 | EKF-diagnostic GmbH | Class B | |
| DiaSpect Control Pack HBT4 | 04048534002448 | EKF-diagnostic GmbH | Class B | |
| extendSURETM Haemoglobin F and A2 Calibrators | 09421902348044 | Canterbury Scientific Limited | Unknown class | |
| extendSURE™ Haemoglobin F and A2 Controls | 09421902348037 | Canterbury Scientific Limited | Unknown class | |
| Glycated hemoglobin quality control | 06972337852482 | B&E BIO-TECHNOLOGY CO., LTD. | Unknown class | |
| HbA1c Control Material | 06941377305876 | Shenzhen Dymind Biotechnology Co., Ltd. | Unknown class | |
| HbA1c Control Material | 06970341684983 | Shenzhen Lifotronic Technology Co., Ltd. | Unknown class | |
| HbA1c Control Material | 06978139078303 | Shenzhen Lifotronic Technology Co., Ltd. | Unknown class | |
| HbA2 & HbF & HbA1c Control | 06977125152423 | Goldsite Diagnostics Inc. | Unknown class | |
| HbA2 & HbF & HbA1c Control | 06977125152430 | Goldsite Diagnostics Inc. | Unknown class | |
| Hb-con high | 04048534002493 | EKF-diagnostic GmbH | Class B | |
| Hb-con low | 04048534002479 | EKF-diagnostic GmbH | Class B | |
| Hb-con norm | 04048534002486 | EKF-diagnostic GmbH | Class B | |
| Hb-con Set 2 | 04048534002509 | EKF-diagnostic GmbH | Class B | |
| Hemoglobin control | 06934822535539 | Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. | Unknown class | |
| Hemoglobin control | 06934822535546 | Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. | Unknown class | |
| Hemoglobin control | 06934822535553 | Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. | Unknown class | |
| Hemoglobin F&A2 Calibrator | 04560189283664 | Tosoh Corporation | Unknown class | |
| Hemoglobin Monitoring control solution | 06939663973199 | Sejoy Biomedical Co., Ltd. | Unknown class | |
| Hemonitor H1 Control Set | 08800076701205 | GenBody Inc. | Class B | |
| RESOLVE Hb FASC Control Kit | 06438147385478 | Wallac Oy | Unknown class | |
| ß-THALASSAEMIA & HbA1c Control Material | 06970341689544 | Shenzhen Lifotronic Technology Co., Ltd. | Class C | |
| ß-THALASSAEMIA & HbA1c Control Material | 06975984062129 | Shenzhen Lifotronic Technology Co., Ltd. | Unknown class | |
| ß-THALASSAEMIA & HbA1c Control Material | 06978139078327 | Shenzhen Lifotronic Technology Co., Ltd. | Unknown class | |
| VALIDATE® HbA1c Test Set | 00850011135327 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® HbA1c Test Set | 00859110005937 | LGC Clinical Diagnostics, Inc. | Unknown class | |
| VALIDATE® HbA1c Test Set | 00859110005944 | LGC Clinical Diagnostics, Inc. | Unknown class | |