Definition: To Aid In The Diagnosis Of Individuals Presenting With Signs And Symptoms Of Pneumonic Or Typhoidal Tularemia With A Qualitative In Vitro Diagnostic (ivd) Detection Of Target Dna Sequences Of Francisella Tularensis.
| Device Type ID | 3525 |
| Device Name | Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit |
| Physical State | Kit Contains 6 Vacuum-sealed Pouches Of Freeze-dried PCR Reagents, Containing 4 Vials Each, And Six Pouches Containing One Tube Each Of Reconstitution Buffer And Reagent Grade Water. Designed To Be Used On The JBAIDS Instrument (K051713). |
| Technical Method | Real-time Polymerase Chain Reaction (PCR)amplification And Detection System. |
| Target Area | Matrices: Whole Blood, Sputum, Colony And Blood Cultures. |
| Regulation Description | Francisella Tularensis Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.3280 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |