Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
A Glomerular Basement Membrane (GBM) Antibody Measurement Device is an in vitro immunological diagnostic device used to detect and measure anti-GBM antibodies in serum, which are pathological autoantibodies associated with Goodpasture syndrome, a severe autoimmune condition causing renal and pulmonary injury. It is FDA Class 2, requiring 510(k) clearance, with product code MVJ under 21 CFR 866.5660 in the Immunology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MVJ
- Device Class
- FDA class 2
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Dec 06, 2007 | Substantially Equivalent | Zeus Scientific, Inc. |
| K072358 | BIOPLEX VASCULITIS KIT | Oct 31, 2007 | Substantially Equivalent | Bio-Rad Laboratories |
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | Jun 25, 2001 | Substantially Equivalent | Scimedx Corp. |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | Aug 09, 1999 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K984619 | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | Feb 23, 1999 | Substantially Equivalent | The Binding Site, Ltd. |
| K984336 | QUANTA LITE GBM ELISA | Feb 08, 1999 | Substantially Equivalent | Inova Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.