Product code DEH
- Device name
- Lambda, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5550
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. | 2018-05-08 |
| K140396 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site Group , Ltd. | 2014-04-16 |
| K083601 | LAMBDA LIGHT CHAINS | SENTINEL CH. SpA | 2009-06-22 |
| K033811 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER | The Binding Site, Ltd. | 2004-01-30 |
| K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II | The Binding Site, Ltd. | 2003-07-15 |
| K023131 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site, Ltd. | 2003-01-21 |
| K010440 | FREELITE LAMBDA FREE KIT | The Binding Site, Ltd. | 2001-04-26 |
| K010441 | FREELITE KAPPA FREE KIT | The Binding Site, Ltd. | 2001-04-26 |
| K003671 | LAMBDA IMMAGE FREELITE KIT | The Binding Site, Ltd. | 2001-02-01 |
| K002563 | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dako Corp. | 1997-12-12 |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | Dako Corp. | 1997-11-06 |
| K940583 | VENTANA CD45 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-10-20 |
| K973393 | CHEMMATE LCA | Ventana Medical Systems, Inc. | 1997-09-25 |
| K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-25 |
| K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-22 |
| K941707 | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-04-21 |
| K941784 | VENTANA ANTI-CD8 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-14 |
| K941604 | VENTANA ANTI-CD4 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-14 |
| K941516 | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-10 |
| K941397 | ANTI-VIMENTIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1997-02-10 |
| K941782 | VENTANA ANTI-CD5 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-09-10 |
| K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION | Dako Corp. | 1996-07-05 |
| K941505 | VENTANNA ANTI-CD3 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-05-30 |
| K941173 | ANTI-KERATIN-HMW PRIMARY ANTI-BODY | Ventana Medical Systems, Inc. | 1996-03-22 |
| K935161 | KERATIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-03-22 |
| K936111 | CHEMMATE SPECIAL STAIN LCA-CD45 | Biotek Solutions, Inc. | 1996-02-27 |
| K940331 | KERATIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | 1996-02-26 |
| K950149 | CHEMMATE(TM) LAMBDA | Biotek Solutions, Inc. | 1995-12-06 |
| K940424 | VENTANA BLUE DETECTION KIT | Ventana Medical Systems, Inc. | 1995-11-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700021111 | Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems | THE BINDING SITE GROUP LIMITED | 2026-02-02 |
| 00817089023505 | Diazyme | DIAZYME LABORATORIES, INC. | 2025-10-22 |
| 00817089023512 | Diazyme | DIAZYME LABORATORIES, INC. | 2025-10-22 |
| 00817089023529 | Diazyme | DIAZYME LABORATORIES, INC. | 2025-10-22 |
| 03607360051122 | FLC Control Level 1 | SEBIA | 2023-03-31 |
| 03607360051139 | FLC Control Level 2 | SEBIA | 2023-03-31 |
| 03607360051030 | FLC Lambda | SEBIA | 2023-03-31 |
| 00630414237473 | N FLC SUPPLEMENTARY REAGENT | Siemens Healthcare Diagnostics Products GmbH | 2018-10-08 |
| 00630414237480 | N FLC CONTROL SL1 | Siemens Healthcare Diagnostics Products GmbH | 2018-10-08 |
| 00630414237497 | N FLC STANDARD SL | Siemens Healthcare Diagnostics Products GmbH | 2018-10-08 |
| 00630414237503 | N FLC CONTROL SL2 | Siemens Healthcare Diagnostics Products GmbH | 2018-10-08 |
| 03607360021002 | CAPILLARYS IMMUNOTYPING | SEBIA | 2018-01-24 |
| 03607360023006 | IT/IF Control | SEBIA | 2018-01-24 |
| 03607360026007 | CAPI 3 IMMUNOTYPING | SEBIA | 2018-01-24 |
| 05051700006460 | Freelite® Human Lambda Free Kit for use on the Roche Cobas Integra® | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006439 | Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006446 | Freelite® Human Lambda Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®80 | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700012201 | Freelite® Human Lambda Free Kit for use on the SPAPLUS – Bulk Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006477 | Freelite® Human Lambda Free Kit for use on the SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006491 | Freelite® Human Lambda Free Kit for use on the Siemens BN™II | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010177 | Sheep Anti-Human Lambda Free Light Chains Immunofixation Grade | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700012102 | Freelite® Human Lambda Free Kit for use on the Roche cobas® c systems | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006415 | Freelite® Human Lambda Free Kit for use on the ADVIA® | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006408 | Freelite® Human Lambda Free Kit for use on the Beckman AU® series | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006392 | Freelite® Human Lambda Free Kit for use on the Siemens BN™II - Bulk Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006286 | Freelite® Human Kappa Free Kit for use on the Beckman AU® series | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| B1761180 | antiserum to Human Lambda (free and bound) | KENT LABORATORIES INC | 2016-09-24 |
| M5255522290 | SPIFE IFE-9 Pentavalent Antisera Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 15099590230463 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 08058056681263 | Lambda light chains | SENTINEL CH. SPA | 2016-07-29 |