Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- KIPFormulations, Balanced Salt Solutions1Product Code
- KIQKit, Culture, Chromosome1Product Code
- KIRCells, Animal And Human, Cultured1Product Code
- KISSera, Animal And Human1Product Code
- KITMedia And Components, Synthetic Cell And Tissue Culture1Product Code
- KIWKit, Mycoplasma Detection1Product Code
- KIXMedia, Mycoplasma Detection1Product Code
- KIYChamber, Slide Culture1Product Code
- KIZDish, Tissue Culture1Product Code
- KJAFlask, Tissue Culture1Product Code
- KJBApparatus, Roller1Product Code
- KJCBottle, Roller, Tissue Culture1Product Code
- KJDSpinner, Flask1Product Code
- KJESpinner System, Cell Culture1Product Code
- KJFSystem, Suspension, Cell Culture1Product Code
- KJHApparatus, Perfusion1Product Code
- KPBMedia And Components, Mycoplasma Detection1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
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- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
Media, Mycoplasma Detection
- Page Type
- Product Code
- Regulation Medical Specialty
- Hematology
- Review Panel
- Pathology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 864.2360
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 864.2360 Mycoplasma detection media and components
§ 864.2360 Mycoplasma detection media and components.
(a) Identification. Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.
(b) Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]