Product code CFF— Immunology
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
- Classification name
- Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 29
- First cleared
- Most recent
Market context for product code CFF
FDA has cleared devices under product code CFF between 1979 and 2021, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2019
- 2018
- 2016
- 2015
- 2012
- 2011
- 2009
- 2006
- 2003
- 2000
- 1999
- 1998
- 1996
- 1994
Top applicants under product code CFF
Recent clearances under product code CFF
- K203184 — HYDRASHIFT 2/4 isatuximab
- K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera
- K190851 — HYDRASHIFT 2/4 daratumumab
- K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control
- K161928 — CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
- K143483 — MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
- K120169 — INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
- K111369 — THE HELENA V8 IMMUNODISPLACEMENT KIT
- K103757 — IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
- K082085 — CAPILLARYS IMMUNOTYPING, MODEL 2100
- K082388 — MINICAP IMMUNOTYPING, MODEL: 2300
- K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- K033187 — INTERLAB IMMUNOFIXATION TEST(S)
- K033277 — HYDRAGEL CSF ISOFOCUSING KITS
- K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
- K002799 — PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
- K993323 — K-ASSAY IGM
- K993213 — K-ASSAY IGA
- K990998 — POLYSLIT IFE KIT
- K981048 — HYDRAGEL 6 CSF KIT
- K973040 — SPIFE IFE-6
- K960669 — HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
- K933972 — N-ASSAY TIA IGG
- K924767 — IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
- K924769 — IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
- K923658 — REP IMMUNOFIX
- K892424 — REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
- K823884 — PARAGON IMMUNOELECTROPHORESIS REAGENT
- K790667 — CORNING PARAPROTEIN SCREENING
Data sourced from openFDA. This site is unofficial and independent of the FDA.