Product code MID— Immunology
SYNELISA CARDIOLIPIN ANTIBODIES
- Classification name
- System, Test, Anticardiolipin Immunological
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Total cleared
- 94
- First cleared
- Most recent
Market context for product code MID
FDA has cleared devices under product code MID between 1991 and 2024, filed by 32 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- 2024
- 2013
- 2012
- 2011
- 2010
- 2006
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
Top applicants under product code MID
Recent clearances under product code MID
- K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
- K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
- K130528 — BIOPLEX 2200 APLS IGM
- K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
- K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
- K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
- K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
- K091845 — CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
- K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
- K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
- K040463 — AESKULISA CARDIOLIPIN AGM
- K032868 — REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
- K032240 — BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
- K030741 — AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
- K024195 — MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
- K024196 — REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
- K023433 — VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
- K022990 — REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
- K022992 — REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
- K021398 — APL IGA ELISA KIT
- K021192 — QACA IGG/IGM ELISA KIT HRP
- K020752 — VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
- K020757 — VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
- K020758 — VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
- K020241 — QACA IGG/IGM ELISA KIT
- K020156 — DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
- K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
- K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
- K013018 — REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
- K012567 — MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
- K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
- K003069 — ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
- K001981 — DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
- K001574 — DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
- K000920 — REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
- K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
- K992449 — AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
- K992440 — AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
- K984102 — ACL/APS FACS KIT
- K983692 — ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
- K983694 — ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
- K983695 — ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
- K983696 — ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
- K984173 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
- K984175 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
- K984347 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
- K981014 — ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
- K981021 — ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
- K981020 — ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
- K973196 — ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
- K971784 — ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
- K970177 — ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
- K971039 — HEMAGEN ANTI CARDIOLIPIN SCREEN
- K962926 — ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
- K962469 — ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
- K955303 — DIASTAT ANTI-CARDIOLIPIN KIT
- K955449 — ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
- K952521 — CARDIOLIPIN IGM EIA TEST SYSTEM
- K952522 — CARDIOLIPIN IGA EIA TEST SYSTEM
- K952523 — CARDIOLIPIN IGG EIA TEST KIT
- K946215 — CARDIOLIPIN G EIA TEST SYSTEM
- K946216 — CARDIOLIPIN A EIA TEST SYSTEM
- K946217 — CARDIOLIPIN M EIA TEST SYSTEM
- K952287 — REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
- K951363 — CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
- K951187 — VARELISA CARDIOLIPIN ABS SCREEN
- K952520 — CARDIOLIPIN IGG,M,A EIA TEST KIT
- K953366 — QUANTA LITE IGA ACA (HRP)
- K953291 — QUANTA LITE ACA SCREEN (HRP)
- K946034 — QUANTA LITE(TM) IGG (HRP)
- K946385 — QUANTA LITE ACA IGM (HRP)
- K933784 — ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)
- K933786 — ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST
- K933788 — ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
- K933588 — APHLELISA KIT
- K940403 — ELIAS CARDIOLIPIN ANTIBODIES
- K941840 — HEMAGEN ACL IGA CALIBRATOR
- K935288 — SYNELISA CARDIOLIPIN ANTIBODIES
- K933392 — ELIAS CARDIOLIPIN IGM ANTIBODIES
- K933393 — ELIAS CARDIOLIPIN IGG ANTIBODIES
- K932373 — HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
- K932225 — ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
- K924421 — SYNELISA CARDIOLIPIN ANTIBODIES
- K922351 — QUANTA LITE(TM) IGA ACA
- K923320 — QUANTA LITE ACA SCREEN
- K923886 — DIASTAT TOTAL ANTI-CARDIOLIPIN KIT
- K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
- K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
- K921265 — DIASTAT ANTI-CARDIOLIPIN KIT
- K921250 — SYNELISA CARDIOLIPIN ANTIBODIES
- K914405 — READS(R) IGA ANTI-CARDIOLIPIN TEST KIT
- K911661 — ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
- K913054 — 3M ANTI-CARDIOLIPIN FAST(TM) TEST
- K911680 — QUANTA LITE(TM) ACA
Data sourced from openFDA. This site is unofficial and independent of the FDA.