Product code MVJ
- Device name
- Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5660
- 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 |
|---|---|---|---|
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Zeus Scientific, Inc. | 2007-12-06 |
| K072358 | BIOPLEX VASCULITIS KIT | Bio-Rad Laboratories | 2007-10-31 |
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | Scimedx Corp. | 2001-06-25 |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | Cogent Diagnotics , Ltd. | 1999-08-09 |
| K984619 | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-23 |
| K984336 | QUANTA LITE GBM ELISA | Inova Diagnostics, Inc. | 1999-02-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00845533002028 | Glomerular Basement Membrane (Primate Kidney) | ZEUS SCIENTIFIC, INC. | 2025-10-17 |
| 04049016135968 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 04049016108832 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 04049016108849 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 04049016108856 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 04049016108863 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 04049016119920 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 04049016135883 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 04049016135890 | EUROPLUS Granulocyte Mosaic 25 EUROPattern | EUROIMMUN Medizinische Labordiagnostika AG | 2018-06-04 |
| 00816879020137 | Autostat II Anti-GBM | HYCOR BIOMEDICAL LLC | 2016-09-26 |
| 07333066010670 | EliA GBM Well | Phadia AB | 2016-09-23 |
| 07333066014630 | EliA GBM Well | Phadia AB | 2016-09-23 |
| 00813545022945 | GBM P KDY Test(L) 96 | SCIMEDX CORPORATION | 2016-09-19 |
| 00813545022938 | GBM P KDY Test(L) 48 | SCIMEDX CORPORATION | 2016-09-19 |
| 05391516747943 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 05391516747585 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 05391516748001 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 05391516748018 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 00813545020583 | P KDY Pack 4 WELL | SCIMEDX CORPORATION | 2016-09-16 |
| 00813545020606 | P KDY Pack 8 WELL | SCIMEDX CORPORATION | 2016-09-16 |
| 00847865011082 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865010955 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002394 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000536 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002387 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950595823 | QUANTA Lite® GBM ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950584650 | QUANTA Flash® GBM Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950454533 | QUANTA Lite® GBM ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |