FDA Product Code
FDA Product Code MID — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 94 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | 2024-12-17 | Traditional | PDF ↗ |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | Phadia US, Inc. | 2013-12-23 | Traditional | PDF ↗ |
| K130528 | BIOPLEX 2200 APLS IGM | Bio-Rad Laboratories | 2013-10-21 | Traditional | PDF ↗ |
| K120817 | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | Inova Diagnostics, Inc. | 2013-02-26 | Traditional | PDF ↗ |
| K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | Immco Diagnostics, Inc. | 2012-10-25 | Traditional | PDF ↗ |
| K103834 | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS | Bio-Rad Laboratories | 2012-03-30 | Traditional | PDF ↗ |
| K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | Zeus Scientific, Inc. | 2011-12-12 | Traditional | PDF ↗ |
| K091845 | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | 2010-06-07 | Traditional | PDF ↗ |
| K092181 | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS | Instrumentation Laboratory CO | 2010-03-11 | Traditional | PDF ↗ |
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | Theratest Laboratories, Inc. | 2006-02-07 | Special | PDF ↗ |
| K040463 | AESKULISA CARDIOLIPIN AGM | Aesku, Inc. | 2004-05-12 | Traditional | PDF ↗ |
| K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | Corgenix, Inc. | 2003-10-14 | Special | PDF ↗ |
| K032240 | BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 2003-09-29 | Traditional | PDF ↗ |
| K030741 | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | Hycor Biomedical , Ltd. | 2003-05-01 | Traditional | PDF ↗ |
| K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2003-01-03 | Special | PDF ↗ |
| K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | Corgenix, Inc. | 2003-01-03 | Special | PDF ↗ |
| K023433 | VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 | Pharmacia Diagnostics GmbH & Co. KG | 2002-11-13 | Traditional | PDF ↗ |
| K022992 | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | Corgenix, Inc. | 2002-09-25 | Special | PDF ↗ |
| K022990 | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | Corgenix, Inc. | 2002-09-25 | Special | PDF ↗ |
| K021398 | APL IGA ELISA KIT | Louisville Apl Diagnostics, Inc. | 2002-08-27 | Traditional | PDF ↗ |
| K021192 | QACA IGG/IGM ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-05-16 | Traditional | PDF ↗ |
| K020758 | VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 | Pharmacia Deutschland GmbH | 2002-05-02 | Traditional | PDF ↗ |
| K020757 | VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 | Pharmacia Deutschland GmbH | 2002-05-02 | Traditional | PDF ↗ |
| K020752 | VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 | Pharmacia Deutschland GmbH | 2002-05-02 | Traditional | PDF ↗ |
| K020241 | QACA IGG/IGM ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-03-13 | Traditional | PDF ↗ |
| K020156 | DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T | Axis-Shield Diagnostics, Ltd. | 2002-03-06 | Traditional | PDF ↗ |
| K012450 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | Diamedix Corp. | 2001-10-26 | Traditional | PDF ↗ |
| K012449 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | Diamedix Corp. | 2001-10-26 | Traditional | PDF ↗ |
| K013018 | REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT | Corgenix, Inc. | 2001-09-20 | Special | PDF ↗ |
| K012567 | MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-08-23 | Special | PDF ↗ |
| K012053 | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM | Diamedix Corp. | 2001-08-20 | Traditional | PDF ↗ |
| K003069 | ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM | Quest Intl., Inc. | 2000-11-27 | Traditional | PDF ↗ |
| K001981 | DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 | Axis-Shield , Ltd. | 2000-08-21 | Traditional | PDF ↗ |
| K001574 | DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 | Axis-Shield | 2000-06-09 | Traditional | PDF ↗ |
| K000920 | REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2000-04-26 | Traditional | PDF ↗ |
| K993085 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA | Cogent Diagnotics , Ltd. | 2000-02-01 | Traditional | PDF ↗ |
| K992449 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA | Cogent Diagnotics , Ltd. | 1999-11-24 | Traditional | PDF ↗ |
| K992440 | AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA | Cogent Diagnotics , Ltd. | 1999-09-21 | Traditional | PDF ↗ |
| K984102 | ACL/APS FACS KIT | Louisville Apl Diagnostics, Inc. | 1999-03-18 | Traditional | PDF ↗ |
| K983694 | ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-05 | Traditional | PDF ↗ |
| K983695 | ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-05 | Traditional | PDF ↗ |
| K983696 | ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-05 | Traditional | PDF ↗ |
| K983692 | ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST | The Binding Site, Ltd. | 1999-02-05 | Traditional | PDF ↗ |
| K984173 | THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K984175 | THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K984347 | THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F | Zeus Scientific, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K981021 | ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM | Zeus Scientific, Inc. | 1998-06-02 | Traditional | PDF ↗ |
| K981014 | ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1998-06-02 | Traditional | PDF ↗ |
| K981020 | ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K973196 | ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS | Zeus Scientific, Inc. | 1997-10-29 | Traditional | PDF ↗ |
| K971784 | ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K970177 | ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA | Immco Diagnostics, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K971039 | HEMAGEN ANTI CARDIOLIPIN SCREEN | Hemagen Diagnostics, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K962926 | ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY | American Laboratory Products Co., Ltd. | 1996-10-10 | Traditional | PDF ↗ |
| K962469 | ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY | American Laboratory Products Co., Ltd. | 1996-09-09 | Traditional | PDF ↗ |
| K955303 | DIASTAT ANTI-CARDIOLIPIN KIT | Shield Diagnostics, Ltd. | 1996-05-30 | Traditional | PDF ↗ |
| K955449 | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY | American Laboratory Products Co., Ltd. | 1996-05-23 | Traditional | PDF ↗ |
| K952522 | CARDIOLIPIN IGA EIA TEST SYSTEM | Immunoprobe, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K952523 | CARDIOLIPIN IGG EIA TEST KIT | Immunoprobe, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K952521 | CARDIOLIPIN IGM EIA TEST SYSTEM | Immunoprobe, Inc. | 1996-02-09 | Traditional | PDF ↗ |
| K946217 | CARDIOLIPIN M EIA TEST SYSTEM | Hogan & Hartson | 1996-01-24 | Traditional | PDF ↗ |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | Hogan & Hartson | 1996-01-24 | Traditional | PDF ↗ |
| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Hogan & Hartson | 1996-01-24 | Traditional | PDF ↗ |
| K952287 | REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT | Reaads Medical Products, Inc. | 1995-12-18 | Traditional | PDF ↗ |
| K951363 | CARDIOLIPIN IGG,M,A EIA TEST SYSTEM | Immunoprobe, Inc. | 1995-10-13 | Traditional | PDF ↗ |
| K951187 | VARELISA CARDIOLIPIN ABS SCREEN | Elias U.S.A., Inc. | 1995-10-02 | Traditional | PDF ↗ |
| K952520 | CARDIOLIPIN IGG,M,A EIA TEST KIT | Immunoprobe, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K953366 | QUANTA LITE IGA ACA (HRP) | Inova Diagnostics, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K953291 | QUANTA LITE ACA SCREEN (HRP) | Inova Diagnostics, Inc. | 1995-08-29 | Traditional | PDF ↗ |
| K946385 | QUANTA LITE ACA IGM (HRP) | Inova Diagnostics, Inc. | 1995-07-18 | Traditional | PDF ↗ |
| K946034 | QUANTA LITE(TM) IGG (HRP) | Inova Diagnostics, Inc. | 1995-07-18 | Traditional | PDF ↗ |
| K933788 | ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST | Immco Diagnostics, Inc. | 1995-03-07 | Traditional | PDF ↗ |
| K933784 | ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) | Immco Diagnostics, Inc. | 1995-03-07 | Traditional | PDF ↗ |
| K933786 | ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST | Immco Diagnostics, Inc. | 1995-03-07 | Traditional | PDF ↗ |
| K933588 | APHLELISA KIT | Louisville Apl Diagnostics, Inc. | 1994-10-13 | Traditional | PDF ↗ |
| K940403 | ELIAS CARDIOLIPIN ANTIBODIES | Elias U.S.A., Inc. | 1994-09-20 | Traditional | PDF ↗ |
| K941840 | HEMAGEN ACL IGA CALIBRATOR | Hemagen Diagnostics, Inc. | 1994-06-30 | Traditional | PDF ↗ |
| K935288 | SYNELISA CARDIOLIPIN ANTIBODIES | Elias U.S.A., Inc. | 1994-01-24 | Traditional | PDF ↗ |
| K933392 | ELIAS CARDIOLIPIN IGM ANTIBODIES | Elias U.S.A., Inc. | 1993-12-08 | Traditional | PDF ↗ |
| K933393 | ELIAS CARDIOLIPIN IGG ANTIBODIES | Elias U.S.A., Inc. | 1993-12-08 | Traditional | PDF ↗ |
| K932373 | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 | Hemagen Diagnostics, Inc. | 1993-07-16 | Traditional | PDF ↗ |
| K932225 | ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM | Immuno Concepts, Inc. | 1993-07-06 | Traditional | PDF ↗ |
| K924421 | SYNELISA CARDIOLIPIN ANTIBODIES | Elias U.S.A., Inc. | 1992-11-30 | Traditional | PDF ↗ |
| K922351 | QUANTA LITE(TM) IGA ACA | Inova Diagnostics, Inc. | 1992-09-29 | Traditional | PDF ↗ |
| K923320 | QUANTA LITE ACA SCREEN | Inova Diagnostics, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923886 | DIASTAT TOTAL ANTI-CARDIOLIPIN KIT | Shield Diagnostics, Ltd. | 1992-09-25 | Traditional | PDF ↗ |
| K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST | General Biometrics, Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST | General Biometrics, Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K921265 | DIASTAT ANTI-CARDIOLIPIN KIT | Shield Diagnostics, Ltd. | 1992-08-03 | Traditional | PDF ↗ |
| K921250 | SYNELISA CARDIOLIPIN ANTIBODIES | Elias U.S.A., Inc. | 1992-06-04 | Traditional | PDF ↗ |
| K914405 | READS(R) IGA ANTI-CARDIOLIPIN TEST KIT | Reads Medical Products, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K911661 | ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM | Immuno Concepts, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K913054 | 3M ANTI-CARDIOLIPIN FAST(TM) TEST | 3M Diagnostic Systems, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K911680 | QUANTA LITE(TM) ACA | Inova Diagnostics, Inc. | 1991-11-19 | Traditional | PDF ↗ |
Product code MID · Class II · Immunology. Data: openFDA.