Radioimmunoassay, Calcitonin
FDA product code JKR · Class II (moderate risk) · 21 CFR 862.1140 · Clinical Chemistry
20510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Diagnostic Systems Laboratories, Inc. 4
- Nichols Institute Diagnostics 3
- Diagnostic Products Corp. 2
- Scantibodies Laboratory, Inc. 2
- Roche Diagnostics Corp. 2
- Cambridge Nuclear Radiopharmaceutical 1
- Endocrine Associates, Inc. 1
- Mitsubishi Yuka America, Inc. 1
- Cis-Us, Inc. 1
- Sangui Biotech, Inc. 1
- Kmi Diagnostics, Inc. 1
- Axis-Shield Diagnostics, Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252431 | Elecsys CalcitoninJKR · Traditional | Roche Diagnostics GmbH | 04/24/2026SE |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | Axis-Shield Diagnostics Limited | 12/21/2018SE |
| K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3JKR · Traditional | Roche Diagnostics | 12/04/2013SE |
| K060578 | Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)JKR · Traditional | Scantibodies Laboratory, Inc. | 08/30/2006SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | Diagnostic Products Corp. | 12/09/2002SE |
| K990073 | CalcitoninJKR · Traditional | Kmi Diagnostics, Inc. | 05/11/1999SE |
| K982491 | Sangui Biotech, Inc. Calcitonin Elisa KitJKR · Traditional | Sangui Biotech, Inc. | 09/03/1998SE |
| K964635 | Nichols Advantage Chemiluminescence Calcitonin KitJKR · Traditional | Nichols Institute Diagnostics | 05/21/1997SE |
| K961043 | Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology)JKR · Traditional | Scantibodies Laboratory, Inc. | 05/06/1996SE |
| K945961 | Calcitonin Immunoassay KitJKR · Traditional | Nichols Institute Diagnostics | 11/20/1995SE |
| K951708 | Elsa-HctJKR · Traditional | Cis-Us, Inc. | 09/05/1995SE |
| K914429 | DSL Ultra-Sensitive Calcitonin Ria (DSL 5200)JKR · Traditional | Diagnostic Systems Laboratories, Inc. | 01/15/1992SE |
| K912536 | Calcitonin Kit Mitsubishi YukaJKR · Traditional | Mitsubishi Yuka America, Inc. | 07/18/1991SE |
| K874087 | Modified Calcitonin Ria Kit DSL #1200JKR · Traditional | Diagnostic Systems Laboratories, Inc. | 02/02/1988SE |
| K872880 | Calcitonin Ria KitJKR · Traditional | Endocrine Associates, Inc. | 08/13/1987SE |
| K861274 | Double Antibody Calcitonin Ria KitJKR · Traditional | Diagnostic Products Corp. | 06/25/1986SE |
| K854240 | Calcitonin Ria KitJKR · Traditional | Diagnostic Systems Laboratories, Inc. | 11/22/1985SE |
| K842907 | Calcitonin Radioimmunoassay KitJKR · Traditional | Nichols Institute Diagnostics | 09/05/1984SE |
| K821675 | Calcitonin Ria Test Kit, DLS 1200JKR · Traditional | Diagnostic Systems Laboratories, Inc. | 06/22/1982SE |
| K781909 | Calcitonin 125JKR · Traditional | Cambridge Nuclear Radiopharmaceutical | 01/10/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0467-2015 Class II | Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the…A potential issue with false high values. | Biomerica | 09/18/2014Terminated |