| Babesia Antibody Rapid Test | 69743840310566 | Zhejiang Anji Saianfu Biotechnology Co., Ltd. | Unknown class | |
| Bioline Filariasis Test Strip (30T) | 00811877011286 | Abbott Diagnostics Scarborough, Inc. | Unknown class | |
| biotical Crypto Card | 84365942152920 | BIOTICAL HEALTH S.L.U | Unknown class | |
| biotical Crypto Card (+PC) | 84365942153088 | BIOTICAL HEALTH S.L.U | Unknown class | |
| biotical Giardia Card | 84365942152470 | BIOTICAL HEALTH S.L.U | Unknown class | |
| biotical Giardia Card (+PC) | 84365942152548 | BIOTICAL HEALTH S.L.U | Unknown class | |
| biotical Giardia Card (+PC +NC) | 84365942152616 | BIOTICAL HEALTH S.L.U | Unknown class | |
| CerTest Crypto | 08435440200666 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto | 08435440201618 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto | 08435440207528 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto+Giardia | 08435440211914 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto+Giardia | 08435440211921 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto+Giardia | 08435440212263 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto+Giardia+Entamoeba | 08435440212584 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto+Giardia+Entamoeba | 08435440212591 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Crypto+Giardia+Entamoeba | 08435440212607 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Entamoeba | 08435440200727 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Entamoeba | 08435440206415 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Entamoeba | 08435440207429 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Giardia+ | 08435440211846 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Giardia+ | 08435440211853 | CERTEST BIOTEC S.L. | Class B | |
| CerTest Giardia+ | 08435440211860 | CERTEST BIOTEC S.L. | Class B | |
| Chagas Ab Rapid Test | 06937339209726 | VivaChek Biotech (Hangzhou) Co., Ltd. | Unknown class | |
| Chagas Detect™ Plus Rapid Test | ++B379CP050UN | InBios International, Inc. | Unknown class | |
| ChainFor Blastocystis hominis + Dientamoeba fragilis Detection qPCR Kit | 08683548257598 | Vitrosens Biotechnology Inc. | Unknown class | |
| ChainFor Moraxella catarrhalis Detection qPCR Kit | 08683548257796 | Vitrosens Biotechnology Inc. | Unknown class | |
| CL Detect™ Rapid Test | ++B379CL025TT | InBios International, Inc. | Unknown class | |
| Crypto+Giardia Combo Antigen Rapid Test | 69743840312478 | Zhejiang Anji Saianfu Biotechnology Co., Ltd. | Unknown class | |
| Cryptosporidium Antigen Rapid Test | 16972698603737 | Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. | Unknown class | |
| Filariasis IgG/IgM Rapid Test | 06937339209535 | VivaChek Biotech (Hangzhou) Co., Ltd. | Unknown class | |
| Filariasis IgG/IgM Rapid Test | 16972698603713 | Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. | Unknown class | |
| Giardia lamblia Rapid Test | 06952804832513 | Assure Tech. (Hangzhou) Co., Ltd. | Class B | |
| Giardia Rapid Test | 06937339209641 | VivaChek Biotech (Hangzhou) Co., Ltd. | Unknown class | |
| JDBiotech | 69301021000158 | Jei Daniel (JD) Biotech Corp. | Unknown class | |
| JDBiotech | 69301021000394 | Jei Daniel (JD) Biotech Corp. | Unknown class | |
| JDBiotech | 69301021002138 | Jei Daniel (JD) Biotech Corp. | Unknown class | |
| Kalazar Detect™ Rapid Test | ++B379INS015VS | InBios International, Inc. | Unknown class | |
| Kalazar Detect™ Rapid Test | ++B379INS0201E | InBios International, Inc. | Unknown class | |
| Kalazar Detect™ Rapid Test | ++B379INS0251J | InBios International, Inc. | Unknown class | |
| LyoSens Moraxella catarrhalis Detection qPCR Kit | 08683548259349 | Vitrosens Biotechnology Inc. | Unknown class | |
| Malaria pf/pv Test Kit(Whole blood) | 86979834610122 | Neo-nostics (Suzhou) Bioengineering Co., Ltd. | Unknown class | |
| Malaria Test Device(whole blood) | 86979834610313 | Neo-nostics (Suzhou) Bioengineering Co., Ltd. | Unknown class | |
| Schistosoma Antibody Test Kit(Serum/plasma/whole blood) | 86979834610047 | Neo-nostics (Suzhou) Bioengineering Co., Ltd. | Unknown class | |
| Simple Crypto-Giardia-Entamoeba | 08429577004907 | OPERON, S.A. | Class B | |
| Simple Crypto-Giardia-Entamoeba 4R | 08429577004112 | OPERON, S.A. | Class B | |
| Simple Crypto-Giardia-Entamoeba 4R | 08429577008103 | OPERON, S.A. | Class B | |
| Simple Crypto-Giardia-Entamoeba 4R | 08429577008110 | OPERON, S.A. | Class B | |
| Top Care | 06223018291008 | Delta Care for Medical Industries Co, Ltd. | Class I | |
| TOXO Toxoplasma Antibody IgG Rapid Test Kit (Colloidal Gold) | 06935091671768 | Qingdao Hightop Biotech Co., Ltd. | Unknown class | |
| TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold) | 06935091671782 | Qingdao Hightop Biotech Co., Ltd. | Unknown class | |
UDI Compass