FDA Device Intelligence
Home › Device types › JKR

Radioimmunoassay, Calcitonin

FDA product code JKR · Class 2 · Clinical Chemistry

21
Registered devices
38
Adverse events
1
Recalls
20
510(k) clearances

Devices with this code

Atellica IM Calcitonin — Siemens Healthcare Diagnostics Inc.Calcitonin AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.ADVIA Centaur Calcitonin — Siemens Healthcare Diagnostics Inc.Calcitonin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.IMMULITE / IMMULITE® 1000 Systems CAL Calcitonin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys Calcitonin — Roche Diagnostics GmbHCalcitonin ELISA — DRG International IncElecsys Calcitonin Immunoassay — Roche Diagnostics GmbHIMMULITE® Systems CONTROL Calcitonin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCalcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.MicroVue — QUIDEL CORPORATIONCalcitonin AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Elecsys Calcitonin — Roche Diagnostics GmbHIMMULITE / IMMULITE® 1000 Systems CAL Calcitonin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems CAL Calcitonin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDScantibodies Laboratory, Inc. — SCANTIBODIES LABORATORY, INC.Calcitonin AccuLite CLIA Test System -192 Wells — MONOBIND, INC.Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.Elecsys Calcitonin — Roche Diagnostics GmbHCalcitonin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungCalcitonin AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.

Recent recalls

DateFirmReason
2014-09-18BiomericaA potential issue with false high values.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.