Definition: The Plasmodium Sp. FISH Is Intended To Detect Plasmodium Spp. Parasites And/or Differentiate Parasite Species In Clinical Whole Blood Smear Specimens From Patients With Signs Or Symptoms Of Malaria And Suspicion Of Infection.
| Device Type ID | 3584 |
| Device Name | Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. |
| Physical State | In Vitro Diagnostic Devices And Reagents That Consist Of Slides, Fixatives, Fluorescently Labeled Probes, Buffers, And Associated Instrumentation (if Applicable) For The Detection And Identification Of Plasmodium Spp. Parasites In Clinical Whole Bloo |
| Technical Method | Fluorescence In Situ Hybridization Using Labeled Nucleic Acid Probes |
| Target Area | Clinical Whole Blood Smear Specimens From Patients Suspected Of Infection With Plasmodium Spp. |
| 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 | 866.3367 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PYN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3584 |
| Device | Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. |
| Product Code | PYN |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3367 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ID-FISH TECHNOLOGY, INC | ||
GRANTED | 1 | |