CEW

Product Code: CEW


Products Classified as CEW

276Radioimmunoassay, Parathyroid HormoneParathyroid Hormone Test System.

Total Product Life Cycle (TPLC) Devices

276Radioimmunoassay, Parathyroid HormoneParathyroid Hormone Test System.

Pre-market Notifications for CEW

K190702Lumipulse G Whole PTHFujirebio Diagnostics, Inc.
K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics Inc.
K161158IDS-iSYS Intact PTHNIMMUNODIAGNOSTIC SYSTEMS LTD
K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin Inc.
K133601ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare Diagnostics Inc.
K132515LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERSDIASORIN, INC.
K121981ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS
K103325IDS-ISYS INTACT PTHIMMUNODIAGNOSTIC SYSTEMS LTD.
K101921VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITORTHO-CLINICAL DIAGNOSTICS
K070709ROCHE ELECSYS PTH TEST SYSTEMROCHE DIAGNOSTICS CORP.
K070391ELECSYS PTH TEST SYSTEMROCHE DIAGNOSTICS CORP.
K063605ST AIA-PACK INTACT PTH ASSAYTosoh BioScience, Inc.
K063232ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01BIOKIT S.A.
K061190ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953BECKMAN COULTER, INC.
K060420MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002SCANTIBODIES LABORATORY, INC.

Global Unique Device Identification Database

00380740136215RADIOIMMUNOASSAY, PARATHYROID HORMONE
00380740048471RADIOIMMUNOASSAY, PARATHYROID HORMONE
00380740017354RADIOIMMUNOASSAY, PARATHYROID HORMONE
00380740017347RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414964980RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414964515RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414961927RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414961910RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414954059RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414953236RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414599458RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414599441RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414592398RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414592381RADIOIMMUNOASSAY, PARATHYROID HORMONE
00630414592343RADIOIMMUNOASSAY, PARATHYROID HORMONE

Maude Adverse Events

ATELLICA IM PARATHYROID HORMONE (PTH) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-03-25
ARCHITECT INTACT PTHABBOTT GMBH2020-03-17
ARCHITECT IPTHABBOTT GMBH2020-03-14
PTH ELECSYS E2G 300ROCHE DIAGNOSTICS2020-03-13
ELECSYS PTH IMMUNOASSAYROCHE DIAGNOSTICS2020-03-10
IMMULITE 2000 XPI - IPTSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2020-02-27
ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-20
ARCHITECT IPTHABBOTT GMBH2020-02-12
ARCHITECT IPTHABBOTT GMBH2020-02-10
ARCHITECT IPTHABBOTT GMBH2020-02-05
ALINITY I INTACT PTHABBOTT GMBH2020-01-30
ELECSYS PTH STAT IMMUNOASSAYROCHE DIAGNOSTICS2020-01-21
PTH ELECSYS E2G 300ROCHE DIAGNOSTICS2020-01-15
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-10
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-10
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-08
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-08
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2020-01-06
ARCHITECT INTACT PTHABBOTT GERMANY2019-11-21
PTH ELECSYS E2G 300ROCHE DIAGNOSTICS2019-11-18
ARCHITECT INTACT PTHABBOTT GERMANY2019-11-13
ARCHITECT INTACT PTHABBOTT GERMANY2019-11-11
PTH ELECSYS E2G 300ROCHE DIAGNOSTICS2019-11-08
ARCHITECT INTACT PTHABBOTT GERMANY2019-10-31
ELECSYS PTH STAT IMMUNOASSAYROCHE DIAGNOSTICS2019-09-26
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-09-25
ELECSYS PTH STAT IMMUNOASSAYROCHE DIAGNOSTICS2019-09-18
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-09-17
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-09-03
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-08-20
ALINITY I INTACT PTHABBOTT GERMANY2019-08-15
ARCHITECT INTACT PTHABBOTT GERMANY2019-08-12
ELECSYS PTH STAT IMMUNOASSAYROCHE DIAGNOSTICS2019-08-12
ARCHITECT INTACT PTHABBOTT GERMANY2019-07-30
ARCHITECT INTACT PTHABBOTT GERMANY2019-07-29
ELECSYS PTH STAT IMMUNOASSAYROCHE DIAGNOSTICS2019-07-26
ELECSYS PTH IMMUNOASSAYROCHE DIAGNOSTICS2019-07-26
PTH ELECSYS E2G 300ROCHE DIAGNOSTICS2019-07-25
ARCHITECT IPTHABBOTT GERMANY2019-07-17
ATELLICA IM INTACT PARATHYROID HORMONE (PTH) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-07-10
ATELLICA IM INTACT PARATHYROID HORMONE (PTH) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-07-10
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-07-02
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-07-02
ARCHITECT INTACT PTHABBOTT GERMANY2019-06-25
ARCHITECT INTACT PTHABBOTT GERMANY2019-06-18
ELECSYS PTH IMMUNOASSAYROCHE DIAGNOSTICS2019-06-17
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-05-28
VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-05-28
ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-05-22
ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-05-22
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.