Device Type ID | 3454 |
Device Name | Dna-reagents, Chlamydia |
Regulation Description | Chlamydia Serological Reagents. |
Regulation Medical Specialty | Microbiology |
Review Panel | Microbiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 866.3120 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | LSK |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
|
Device Type ID | 3454 |
Device | Dna-reagents, Chlamydia |
Product Code | LSK |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Chlamydia Serological Reagents. |
CFR Regulation Number | 866.3120 [🔎] |