| Adellgene® Fragile X 100 tests | 08437016942475 | Blackhills Diagnostic Resources S.L.U. | Class C | |
| Adellgene® Fragile X 25 tests | 08437016942468 | Blackhills Diagnostic Resources S.L.U. | Class C | |
| Adellgene® Fragile X Screening 16 tests | 08437016942291 | Blackhills Diagnostic Resources S.L.U. | Unknown class | |
| Adellgene® Fragile X Screening 48 tests | 08437016942307 | Blackhills Diagnostic Resources S.L.U. | Unknown class | |
| AmplideX Fragile X Dx & Carrier Screen Kit | 00850017493124 | Asuragen, Inc. | Class C | |
| AmplideX mPCR FMR1 Test | 00850017493049 | Asuragen, Inc. | Unknown class | |
| PCR-CE FMR1 Kit | 06975358885002 | Xiamen Biofast Biotechnology Co., Ltd. | Unknown class | |
| PCR-CE FMR1 Kit | 06975358885019 | Xiamen Biofast Biotechnology Co., Ltd. | Unknown class | |