Device Type ID | 3000 |
Device Name | Antinuclear Antibody, Indirect Immunofluorescent, 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 | DHN |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 3000 |
Device | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Product Code | DHN |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Antinuclear Antibody Immunological Test System. |
CFR Regulation Number | 866.5100 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
EUROIMMUN U.S., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EUROIMMUN US | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMMCO DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMMUNO CONCEPTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INOVA DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |