| Xpert Hemorrhagic Fever (K261362) | Cepheid | 2026-08-07 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut (K261027) | Hycor Biomedical | 2026-07-24 |
| NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut (K260591) | Hycor Biomedical | 2026-07-21 |
| EliA CTD 13 Screen (K253367) | Phadia AB | 2026-06-25 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg (K260280) | Hycor Biomedical | 2026-06-18 |
| Lipoprotein (a) Molarity Assay (K253069) | Diazyme Laboratories, Inc. | 2026-06-16 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) (K260059) | Hycor Biomedical | 2026-05-15 |
| Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB (K250814) | Zeus Scientific | 2026-05-08 |
| Tina-quant Cardiac high sensitivity CRP III (K260026) | Roche Diagnostics | 2026-04-02 |
| Francisella tularensis Real-time PCR Assay (K260812) | Centers for Disease Control and Prevention | 2026-03-30 |
| Aptiva APS IgA Reagent (K243979) | Inova Diagnostics, Inc. | 2026-02-06 |
| NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg (K252775) | Hycor Biomedical | 2026-01-16 |
| Atellica IM Total PSA II (tPSAII) (K251630) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 |
| LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (DEN250032) | DiaSorin, Inc. | 2025-12-23 |
| NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) (K252493) | Hycor Biomedical | 2025-12-23 |
| Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (K253358) | Diazyme Laboratories, Inc. | 2025-12-19 |
| ADVIA Centaur Cytokeratin Fragment 21-1 (K250925) | Fujirebio Diagnostics,Inc. | 2025-12-16 |
| ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| Alegria Flash CTD Screen (K250666) | Zeus Scientific | 2025-10-22 |
| ADVIA Centaur Anti-Thyroid Peroxidase II (K250250) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159) | The Binding Site Group , Ltd. | 2025-10-17 |
| Elecsys Phospho-Tau (181P) Plasma (K252163) | Roche Diagnostics | 2025-10-08 |
| Francisella tularensis Real-time PCR assay (K252072) | Centers for Disease Control and Prevention | 2025-09-30 |
| Alegria Flash ENA Screen (K250408) | Zeus Scientific | 2025-09-19 |
| Atellica IM Thyroglobulin (Tg) (K242981) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 |
| APO-Easy Genotyping kit (DEN240032) | Firalis SA | 2025-06-12 |
| Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549) | The Binding Site Group , Ltd. | 2025-05-23 |
| Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706) | Fujirebio Diagnostics,Inc. | 2025-05-16 |
| Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (K243776) | Zeus Scientific | 2025-05-07 |
| NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz (K242531) | Hycor Biomedical | 2025-04-23 |
| K-ASSAY CRP (Ver.2) (K242170) | Kamiya Biomedical Company, LLC | 2025-04-18 |
| Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220) | Roche Diagnostics Operations | 2025-01-24 |
| GlutenID Celiac Genetic Health Risk Test (K241456) | Targeted Genomics, LLC | 2025-01-07 |
| Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (K223093) | Inova Diagnostics, Inc. | 2024-12-17 |
| Access TPO Antibody (K240469) | Beckman Coulter, Inc. | 2024-08-09 |
| Access Thyroglobulin Antibody II (K240996) | Beckman Coulter, Inc. | 2024-07-03 |
| Access sTfR (K240987) | Beckman Coulter, Inc. | 2024-07-03 |
| Access Thyroglobulin (K240927) | Beckman Coulter, Inc. | 2024-06-28 |
| Access Thyroglobulin (K241423) | Beckman Coulter, Inc. | 2024-06-07 |
| Kenota 1 Total IgE; Kenota 1 (instrument) (K231151) | Kenota, Inc. | 2024-05-31 |
| Access OV Monitor (K240479) | Beckman Coulter, Inc. | 2024-05-10 |
| Access BR Monitor (K240403) | Beckman Coulter, Inc. | 2024-05-09 |
| VIDAS TBI (GFAP, UCH-L1) (K240279) | bioMerieux, Inc. | 2024-05-01 |
| i-STAT TBI Cartridge with the i-STAT Alinity System (K234143) | Abbott Point of Care | 2024-03-27 |
| Access Ferritin (K234052) | Beckman Coulter, Inc. | 2024-03-20 |
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (K231601) | Sebia | 2024-02-23 |
| BÜHLMANN fCAL® turbo and CALEX® Cap (K232057) | Bühlmann Laboratories AG | 2024-02-06 |
| Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (K231290) | The Binding Site, Ltd. | 2024-01-24 |
| Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (K233242) | Siemens Healthcare Diagnostics, Inc. | 2024-01-18 |
| N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (K233663) | Siemens Healthcare Diagnostics Products GmbH | 2023-12-13 |
| CardioPhase® hsCRP (K232624) | Siemens Healthcare Diagnostic Products GmbH | 2023-11-27 |
| EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748) (DEN220090) | Stemcell Technologies Canada, Inc. | 2023-11-06 |
| Aptima Trichomonas vaginalis Assay (K231316) | Hologic, Inc. | 2023-11-06 |
| Elecsys Tg II (K221890) | Roche Diagnostics | 2023-09-30 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| Aptiva CTD Essential Reagent (K213403) | Inova Diagnostics, Inc. | 2023-09-29 |
| Access Thyroglobulin Antibody II (K213517) | Beckman Coulter, Inc. | 2023-09-26 |
| Access CEA (K223921) | Beckman Coulter, Inc. | 2023-09-22 |
| Access Myoglobin (K231832) | Beckman Coulter, Inc. | 2023-09-18 |
| B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC (K222251) | B.R.A.H.M.S GmbH, Part of Thermo Fisher | 2023-09-18 |
| Elecsys Anti-Tg (K222610) | Roche Diagnostics | 2023-09-15 |
| T2 Biothreat Panel (K231336) | T2biosystems, Inc. | 2023-09-15 |
| Access Thyroglobulin (K220972) | Beckman Coulter, Inc. | 2023-09-15 |
| IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (K213510) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 |
| ZEUS IFA(TM) nDNA Test System, ZEUS dIFine (K231616) | Zeus Scientific | 2023-08-31 |
| KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K220085) | Kronus, Inc. | 2023-08-24 |
| VITROS Immunodiagnostic Products CEA Reagent Pack (K231517) | Ortho Clinical Diagnostics | 2023-08-23 |
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
| Immunoglobulin G (IgG) (K221114) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-08-02 |
| Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348) | Roche Diagnostics | 2023-06-05 |
| Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System (K203599) | Immuno Concepts, N.A. , Ltd. | 2023-05-26 |
| Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (K203245) | Nucleix , Ltd. | 2023-05-04 |
| ALPCO Calprotectin Immunoturbidimetric Assay (K220763) | ALPCO | 2023-04-13 |
| BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (K213362) | Biofire Defense, LLC | 2023-03-22 |
| RCRP Flex reagent cartridge (K221119) | Siemens Healthcare Diagnostics, Inc. | 2023-03-17 |
| Traumatic brain injury (TBI) test (K223602) | Abbott Laboratories | 2023-03-02 |
| Idylla MSI Test (K211181) | Biocartis NV | 2023-02-27 |
| Quantia IgE (K214068) | Biokit, S.A. | 2023-02-21 |
| BOND MMR Antibody Panel (K213348) | Leica Biosystems Newcastle, Ltd. | 2023-02-21 |
| Lp(a) Ultra (K211058) | SENTINEL CH. SpA | 2022-12-22 |
| CardioPhase® hsCRP (K212559) | Siemens Healthcare Diagnostics Products GmbH | 2022-12-16 |
| VITROS Immuodiagnostic Products CA 125 II Reagent Pack (K221355) | Ortho Clinical Diagnostics | 2022-12-12 |
| Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (K221842) | Roche Diagnostics | 2022-12-07 |
| FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (K210623) | Sebia | 2022-11-18 |
| Eonis SCID-SMA kit (K203035) | Perkinelmer, Inc. | 2022-11-09 |
| Eonis SCID-SMA Kit (DEN200044) | Perkinelmer, Inc. | 2022-11-09 |
| Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge (K201256) | Procise Diagnostics | 2022-11-04 |
| AlphaID™ At Home Genetic Health Risk Service (K221420) | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 |
| SPIFE A1AT kit (K213396) | Helena Laboratories, Corp. | 2022-10-13 |
| Elecsys AFP (K220176) | Roche Diagnostics | 2022-09-15 |
| Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K211648) | Diazyme Laboratories, Inc. | 2022-09-08 |
| MammaPrint FFPE NGS Kit (K210973) | Agendia, Inc. | 2022-09-08 |
| Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K220001) | Diazyme Laboratories, Inc. | 2022-08-04 |
| ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed (K212181) | Phadia AB | 2022-08-03 |
| DiviTum TKa (K202852) | Biovica International AB | 2022-07-29 |
| EliA Ro52, EliA Ro60 (K210902) | Phadia AB | 2022-07-27 |
| LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (K213858) | DiaSorin, Inc. | 2022-07-26 |
| VITROS AFP (K213626) | Ortho Clinical Diagnostics | 2022-06-15 |
| Parsortix PC1 Device (DEN200062) | Angle Europe , Ltd. | 2022-05-24 |