21 CFR 866.5660 — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5660
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | 24 | 3rd Party |
| MID | System, Test, Anticardiolipin Immunological | 2 | 94 | 3rd Party |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 74 | 3rd Party |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | 46 | 3rd Party |
| MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | 2 | 6 | 3rd Party |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | 40 | 3rd Party |
| MVS | Kit, Typing, Hla-Dqb | 2 | 1 | |
| NBO | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | 2 | 2 | 3rd Party |
| NBS | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | 2 | 3 | 3rd Party |
| NIY | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | 2 | 3 | 3rd Party |
| NST | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking | 2 | 4 | 3rd Party |
| NWG | Autoantibodies, Glutamic Acid Decarboxylase (Gad) | 2 | 2 | 3rd Party |
| OCN | Insulin Autoantibody Kit | 2 | 1 | 3rd Party |
| OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | 2 | 3 | 3rd Party |
| OIF | Tyrosine Phosphatase (Ia-2) Autoantibody Assay | 2 | 3 | 3rd Party |
| OPN | Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex | 2 | 1 | 3rd Party |
| OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | 1 | 3rd Party |
| PAF | Voltage Gated Calcium Channel (Vgcc) Antibody Assay | 2 | 1 | 3rd Party |
| PCG | 21-Hydroxylase Antibody (21-Ohab) | 2 | 2 | 3rd Party |
