Immunoelectrophoretic, Immunoglobulins, (G, A, M)
FDA product code CFF · 28 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.5510
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1979-07-24 – 2021-11-12
CFF
2021-11-12
CFF
2019-11-01
CAPI 3 Immunotyping, Capillarys 3 Tera
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CFF
2019-05-02
HYDRASHIFT 2/4 daratumumab
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CFF
2018-01-11
HYDRASHIFT 2/4 daratumumab, daratumumab Control
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CFF
2016-12-21
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
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CFF
2012-08-24
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
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CFF
2012-06-26
THE HELENA V8 IMMUNODISPLACEMENT KIT
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CFF
2011-10-13
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
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CFF
2009-04-17
CAPILLARYS IMMUNOTYPING, MODEL 2100
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CFF
2009-04-14
MINICAP IMMUNOTYPING, MODEL: 2300
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CFF
2006-07-06
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
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CFF
2003-11-19
INTERLAB IMMUNOFIXATION TEST(S)
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CFF
2003-11-04
HYDRAGEL CSF ISOFOCUSING KITS
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CFF
2003-02-19
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
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CFF
2000-10-05
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
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CFF
1999-11-30
K-ASSAY IGM
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CFF
1999-11-23
K-ASSAY IGA
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CFF
1999-06-28
POLYSLIT IFE KIT
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CFF
1998-10-07
HYDRAGEL 6 CSF KIT
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CFF
1998-01-02
SPIFE IFE-6
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CFF
1996-07-12
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
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CFF
1994-03-22
N-ASSAY TIA IGG
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CFF
1993-02-23
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
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CFF
1993-02-23
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
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CFF
1992-11-02
REP IMMUNOFIX
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CFF
1989-06-09
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
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CFF
1983-03-07
PARAGON IMMUNOELECTROPHORESIS REAGENT
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CFF
1979-07-24
CORNING PARAPROTEIN SCREENING
View details →No matching devices.
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