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| CAP BDS KitExact Sciences CorporationNucleic acid extraction/isolation kit IVD | 100313 | Exact Sciences Corporation | Nucleic acid extraction/isolation kit IVD |
| CAP SLNExact Sciences CorporationNucleic acid extraction/isolation kit IVD | 100251 | Exact Sciences Corporation | Nucleic acid extraction/isolation kit IVD |
| ColoSense Collection KitGeneoscopy, Inc.Faecal specimen collection kit IVD, home-use | 0 | Geneoscopy, Inc. | Faecal specimen collection kit IVD, home-use |
| D CAL 2 KitExact Sciences CorporationNucleic acid amplification mastermix kit IVD | 100305 | Exact Sciences Corporation | Nucleic acid amplification mastermix kit IVD |
| D CAL 3 KitExact Sciences CorporationNucleic acid amplification mastermix kit IVD | 100306 | Exact Sciences Corporation | Nucleic acid amplification mastermix kit IVD |
| D CTRL 3 KitExact Sciences CorporationExogenous DNA/RNA internal control IVD, kit | 100303 | Exact Sciences Corporation | Exogenous DNA/RNA internal control IVD, kit |