Radioassay, Vitamin B12
FDA product code CDD · 75 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1810
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-12-06 – 2024-07-31
CDD
2024-07-31
CDD
2022-12-23
Access Vitamin B12
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CDD
2019-10-04
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
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CDD
2019-10-02
LIAISON Vitamin B12
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CDD
2017-10-27
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
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CDD
2016-09-20
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
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CDD
2016-07-26
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
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CDD
2013-03-22
AXIS-SHIELD ACVTIVE-B12
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CDD
2012-11-30
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
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CDD
2012-07-26
A/C ENZYMATIC VITAMIN B6 ASSAY
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CDD
2012-05-17
ARCHITECT B12
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CDD
2011-12-19
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
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CDD
2011-10-06
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
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CDD
2011-05-11
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
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CDD
2010-02-12
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
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CDD
2009-05-27
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
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CDD
2007-11-13
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
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CDD
2006-11-22
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
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CDD
2006-04-28
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
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CDD
2006-04-10
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
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CDD
2005-08-03
ABBOTT AXSYM B12
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CDD
2004-07-02
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
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CDD
2004-01-29
HOLOTC RIA
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CDD
2002-01-24
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
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CDD
1999-12-16
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
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CDD
1999-01-22
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
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CDD
1997-11-13
ELECSYS VITAMIN B12 ASSAY
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CDD
1997-11-12
ELECSYS FOLATE
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CDD
1997-05-16
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
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CDD
1997-03-24
AXSYM B12
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CDD
1997-01-13
AIA-PACK B12 ASSAY
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CDD
1996-05-23
BUHLMANN VITAMIN B6 REA
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CDD
1996-01-24
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
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CDD
1995-08-23
OPUS B12
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CDD
1995-07-11
CEDIA VITAMIN B12 (NO BOIL) ASSAY
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CDD
1994-08-15
VISTA B12 ASSAY
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CDD
1993-11-05
ACCESS VITAMIN B12 ASSAY
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CDD
1993-08-25
RADIAS B12 ENZYME IMMUNOASSAY
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CDD
1992-10-26
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
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CDD
1992-02-14
AFFINITY B12
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CDD
1991-10-25
CIBA CORNING ACS T3 IMMUNOASSAY
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CDD
1991-03-06
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
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CDD
1990-11-20
CEDIA (R) VITAMIN B12/FOLATE ASSAY
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CDD
1988-11-04
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
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CDD
1986-07-11
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
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CDD
1986-02-11
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
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CDD
1985-10-03
PHASE II B-12/FOLATE KIT
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CDD
1985-09-16
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
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CDD
1985-08-21
DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
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CDD
1984-06-25
VITAMIN B12 57CO/FOLATE 125I -
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CDD
1984-01-30
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
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CDD
1983-12-08
DIAGNON B12 57CO RIA KIT
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CDD
1983-10-19
QUANTAPHASE B-12-COBALMIN-FOLATE-
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CDD
1983-10-04
VITAMIN B12 FOLATE CA-1515-125
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CDD
1983-10-04
VITAMIN B12 RADIOASSAY KIT CA-1534
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CDD
1983-09-29
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
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CDD
1983-03-10
NO-BOIL SOLID PHASE SIMUL TRAC B12
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CDD
1983-02-18
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
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CDD
1982-03-05
NO-BOIL VITABIN B12 5760 FOLATE 125I
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CDD
1981-12-17
NO-HOIL COMBOSTAT II KIT
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CDD
1981-01-16
'NO-BOIL' VITAMIN B12 KIT
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CDD
1981-01-09
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
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CDD
1980-10-23
VITAMIN B12 - NO-BOIL KIT
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CDD
1980-10-23
COMBOSTAT - NO-BOIL KIT
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CDD
1980-02-13
CALBIOCHEM-BEHRING RIA-COUNT
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CDD
1979-11-13
RIANEN, VITAMIN B12 ASSAY SYSTEM
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CDD
1979-11-13
CENTRIA VITAMIN B12 FOLATE RADIO SET
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CDD
1979-09-27
AUTO PAK VITAMIN B-12
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CDD
1979-02-28
RIA KIT, VITAMIN B12
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CDD
1978-09-27
RIALYZE VITAMIN B-12 TEST
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CDD
1978-06-13
VITAMIN B12 RADIOASSAY
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CDD
1977-06-27
QUANTA-MATE VITAMIN B-12/FOLATE RA
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CDD
1977-03-21
VITAMIN B12 RADIOASSAY
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CDD
1976-12-21
B12/FOLATE SING. TUBE DUAL RADIOASSAY KT
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CDD
1976-12-06
RADIO IMMUNO ASSAY KIT/
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