Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
PYN is the FDA product code for Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp., a class II device type, regulated under 21 CFR 866.3367. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PYN
- Device name
- Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
- FDA 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.
- Regulation
- 21 CFR 866.3367
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PYN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2017 | 1 |
Applicants with the most clearances
Product code PYN| Applicant | Clearances |
|---|---|
| ID-Fish Technology, Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PYN.
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