CDD

Product Code: CDD


Products Classified as CDD

241Radioassay, Vitamin B12Vitamin B[bdi1][bdi2] Test System.

Total Product Life Cycle (TPLC) Devices

241Radioassay, Vitamin B12Vitamin B[bdi1][bdi2] Test System.

Pre-market Notifications for CDD

K192064LIAISON Vitamin B12DiaSorin Inc.
K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH
K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics Ltd.
K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories
K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, And ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)AXIS-SHIELD DIAGNOSTICS LIMITED
K151786Elecsys Vitamin B12 II Assay, Elecsys Vitamin B12 II CalSetRoche Diagnostics
K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive HTSH Assay, Power Express Sample Processing System Generic Connection Module And Access Immunoassay System ReagentsBECKMAN COULTER, INC.
K133512LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)SIEMENS HEALTHCARE DIAGNOSTICS
K121994DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATORSiemens Healthcare Diagnostics Inc.
K121946AXIS-SHIELD ACVTIVE-B12AXIS-SHIELD DIAGNOSTICS, LTD.
K121314ARCHITECT B12ABBOTT LABORATORIES
K112443ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)AXIS-SHIELD DIAGNOSTICS, LTD.
K111260A/C ENZYMATIC VITAMIN B6 ASSAYANTICANCER INC
K110579ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLSABBOTT LABORATORIES
K110413POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONSBECKMAN COULTER, INC.

Global Unique Device Identification Database

00380740136703RADIOASSAY, VITAMIN B12
00380740136697RADIOASSAY, VITAMIN B12
00380740014193RADIOASSAY, VITAMIN B12
00380740014179RADIOASSAY, VITAMIN B12
00380740014131RADIOASSAY, VITAMIN B12
00630414976624RADIOASSAY, VITAMIN B12
00630414964874RADIOASSAY, VITAMIN B12
00630414954448RADIOASSAY, VITAMIN B12
00630414603100RADIOASSAY, VITAMIN B12
00630414600314RADIOASSAY, VITAMIN B12
00630414600291RADIOASSAY, VITAMIN B12
00630414600284RADIOASSAY, VITAMIN B12
00630414600277RADIOASSAY, VITAMIN B12
00630414598611RADIOASSAY, VITAMIN B12
00630414598345RADIOASSAY, VITAMIN B12

Maude Adverse Events

ARCHITECT B12A.I.D.D LONGFORD2019-11-20
ACCESS VITAMIN B12 REAGENTBECKMAN COULTER2019-11-15
POWER EXPRESSBECKMAN COULTER2019-11-08
ELECSYS VITAMIN B12 IIROCHE DIAGNOSTICS2019-10-23
DYNAMIC INLET, PLC (BULK READY), POWER EXPRESSBECKMAN COULTER2019-08-29
GENERIC CONNECTION UNIT (NCCLS)BREA DISCRETE MFG IO2019-08-26
ARCHITECT B12A.I.D.D LONGFORD2019-08-14
ELECSYS VITAMIN B12 IIROCHE DIAGNOSTICS2019-08-07
HSCA, END USER ACCURATE DIAGNOSTICSBREA DISCRETE MFG IO2019-07-11
ATELLICA IM VITAMIN B12SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-06-28
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL:BREA DISCRETE MFG IO2019-04-23
ACCESS VITAMIN B12 REAGENTBECKMAN COULTER2019-02-12
ELECSYS VITAMIN B12 IIROCHE DIAGNOSTICS2019-01-29
ADVIA CENTAUR XP VB12 ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-12-13
DXI (CLSI) CONNECTION, POWER EXPRESSBECKMAN COULTER2018-12-13
ACCESS VITAMIN B12 REAGENTCLARE DISCRETE MFG IO2018-10-19
ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-10-16
ELECSYS VITAMIN B12 IIROCHE DIAGNOSTICS2018-10-09
ELECSYS VITAMIN B12 IMMUNOASSAYROCHE DIAGNOSTICS2018-09-19
ARCHITECT B12A.I.D.D LONGFORD2018-09-14
ELECSYS VITAMIN B12 IMMUNOASSAYROCHE DIAGNOSTICS2018-08-01
AIA-2000TOSOH CORPORATION2018-01-10
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-09-25
ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-09-12
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-07-11
ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-06-16
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-06-09
ARCHITECT I2000SR ANALYZERABBOTT MANUFACTURING INC2017-05-18
ARCHITECT B12A.I.D.D LONGFORD2017-05-09
ELECSYS VITAMIN B12 IMMUNOASSAYROCHE DIAGNOSTICS2017-03-31
ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-03-30
ADVIA CENTAUR XP VB12 ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-03-16
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-03-10
ACCESS B12 REAGENTBECKMAN COULTER2017-02-07
ELECSYS VITAMIN B12 IMMUNOASSAYROCHE DIAGNOSTICS2017-01-26
VITAMIN B12ROCHE DIAGNOSTICS2016-11-28
ADVIA CENTAUR XPT VB12 ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2016-07-19
ADVIA CENTAUR XP VB12 ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2016-06-29
ACCESS VITAMIN B12BECKMAN COULTER2016-05-03
ACCESS VITAMIN B12BECKMAN COULTER2016-03-04
ACCESS VITAMIN B12BECKMAN COULTER2016-03-04
ARCHITECT B12A.I.D.D LONGFORD2015-12-22
COBAS E411 RACK SYSTEMROCHE DIAGNOSTICS2015-06-19
VITAMIN B12ROCHE DIAGNOSTICS2015-06-01
ACCESS VITAMIN B 12 REAGENTBECKMAN COULTER2015-03-06
ACCESS VITAMIN B12BECKMAN COULTER2015-01-01
ARCHITECT ACTIVE-B12ABBOTT GERMANY2014-12-24
ACCESS VITAMIN B12 ASSAYBECKMAN COULTER2014-09-16
ADVIA CENTAUR XP VB12 ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2014-07-15
ACCESS VITAMIN B12 ASSAYBECKMAN COULTER2014-07-12

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