Last synced on 6 December 2024 at 11:05 pm

Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

Page Type
Product Code
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.
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 blood smear specimens.
Technical Method
Fluorescence In Situ Hybridization using labeled nucleic acid probes
Target Area
Target Area Clinical whole blood smear specimens from patients suspected of infection with Plasmodium spp.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3367
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code PYN is linked to regulation 21CFR866.3367, which does not seem to exist yet. It may be pending at the moment.

Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

Page Type
Product Code
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.
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 blood smear specimens.
Technical Method
Fluorescence In Situ Hybridization using labeled nucleic acid probes
Target Area
Target Area Clinical whole blood smear specimens from patients suspected of infection with Plasmodium spp.
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3367
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code PYN is linked to regulation 21CFR866.3367, which does not seem to exist yet. It may be pending at the moment.