| A-400 TOTAL IgE | 05907514674312 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| A-800 TOTAL IgE | 05907514678488 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| abia IgE total | 04262351590050 | AB Diagnostic Systems GmbH | Unknown class | |
| ACCENT-200 TOTAL IgE | 05907514672318 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| ACCENT-300 TOTAL IgE | 05907514602360 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| AccuDiagTM Total Human IgE | 00850054026477 | Diagnostic Automation/ Cortez Diagnostics, Inc. | Unknown class | |
| AdvanSure™ AlloScreen Max 108 Panel | 08809975010050 | Invitros Co., Ltd | Unknown class | |
| ADVIA Centaur Total IgE | 00630414177472 | Siemens Healthcare Diagnostics Inc. | Unknown class | |
| ADVIA Centaur Total IgE | 00630414177489 | Siemens Healthcare Diagnostics Inc. | Unknown class | |
| AIA-PACK IgEII CALIBRATOR SET | 04560189211070 | Tosoh Corporation | Unknown class | |
| AIA-PACK IgE SAMPLE DILUTING SOLUTION | 04560189211087 | Tosoh Corporation | Unknown class | |
| Alinity c IgE Reagent Kit | 00380740151041 | Biokit S.A. | Class B | |
| Alinity c IgE Standard | 00380740151034 | Biokit S.A. | Class B | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 16974969790030 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 16974969790092 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 26974969790037 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 26974969790099 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 36974969790034 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 36974969790096 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 46974969790031 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 46974969790093 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 56974969790090 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 66974969790097 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 76974969790094 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Allergen-Specific IgE Antibody Rapid Test Kit (FIA) | 86974969790091 | Chongqing iSIA BIO-Technology Co., Ltd. | Unknown class | |
| Atellica IM Total IgE (tIgE) | 00630414599373 | Siemens Healthcare Diagnostics Inc. | Unknown class | |
| Atellica IM Total IgE (tIgE) | 00630414599380 | Siemens Healthcare Diagnostics Inc. | Unknown class | |
| BioCLIA Total IgE Reagent Kit | 06924030410605 | HOB Biotech Group Corp., Ltd. | Unknown class | |
| BioCLIA Total IgE Reagent Kit | 06924030410612 | HOB Biotech Group Corp., Ltd. | Unknown class | |
| BioCLIA Total IgE Reagent Kit | 06924030410629 | HOB Biotech Group Corp., Ltd. | Unknown class | |
| CL AIA-PACK IgE ADJUSTER SET | 14562185400981 | Tosoh Corporation | Unknown class | |
| CL AIA-PACK IgE TEST CUP | 14562185400974 | Tosoh Corporation | Unknown class | |
| CORMAY TOTAL IgE | 05907514663040 | PZ CORMAY Spółka Akcyjna | Unknown class | |
| DS-EIA-IgE TOTAL | 04605979402181 | RPC Diagnostic Systems Ltd. | Unknown class | |
| Dynamiker Total IgE Ab Assay (POCT Chemiluminescence) | 06930317802810 | Dynamiker Biotechnology (Tianjin) Co., Ltd. | Unknown class | |
| Dynamiker Total IgE Ab Assay (POCT Chemiluminescence) | 06930317802872 | Dynamiker Biotechnology (Tianjin) Co., Ltd. | Unknown class | |
| Dynamiker Total IgE Assay(Chemiluminescence) | 06930317802438 | Dynamiker Biotechnology (Tianjin) Co., Ltd. | Unknown class | |
| Dynamiker Total IgE Assay(Chemiluminescence) | 06930317802445 | Dynamiker Biotechnology (Tianjin) Co., Ltd. | Unknown class | |
| Evo Total E | 08058945155752 | ABD SRL | Class A | |
| Evo Total E | 08058945155769 | ABD SRL | Class A | |
| Evo Total SPA | 48058945154456 | ABD SRL | Class A | |
| Evo Total SPA | 48058945154463 | ABD SRL | Class A | |
| FA FIA | 06977903346617 | GeneSign Biotech (Xiamen)Co., Ltd. | Unknown class | |
| FA FIA | 06977903346624 | GeneSign Biotech (Xiamen)Co., Ltd. | Unknown class | |
| Finecare | 06933289807395 | Guangzhou Wondfo Biotech Co., Ltd. | Unknown class | |
| Free IgE Assay Kit (Fluorescence Immunoassay) | 06975424223257 | DiYaLab ZJG Biotech Co., Ltd | Unknown class | |
| Free IgE Assay Kit (Fluorescence Immunoassay) | 06975424223998 | DiYaLab ZJG Biotech Co., Ltd | Unknown class | |
| Free IgE Assay Kit (Fluorescence Immunoassay) | 06975424225725 | DiYaLab ZJG Biotech Co., Ltd | Unknown class | |
| Gesamt IgE | 04260153751310 | Gold Standard Diagnostics Kassel GmbH | Unknown class | |
| ichroma™ Total IgE | 08806133045473 | Boditech Med Inc. | Class B | |