Device Type ID | 3031 |
Device Name | Antinuclear Antibody, Antigen, Control |
Regulation Description | Antinuclear Antibody Immunological Test System. |
Regulation Medical Specialty | Immunology |
Review Panel | Immunology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 866.5100 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | LKJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 3031 |
Device | Antinuclear Antibody, Antigen, Control |
Product Code | LKJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Antinuclear Antibody Immunological Test System. |
CFR Regulation Number | 866.5100 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Euro Diagnostica AB | III | Oct-11-2018 |
2 | Euro Diagnostica AB | III | Aug-23-2018 |
3 | Euro Diagnostica AB | II | Mar-08-2018 |
4 | Euro Diagnostica AB | II | Dec-20-2017 |