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
- NeurologyReview Panel
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- PathologyReview Panel
- 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
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Apparatus, Roller
- Page Type
- Product Code
- Regulation Medical Specialty
- Hematology
- Review Panel
- Pathology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 864.2240
- GMP Exempt?
- Yes
- 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 § 864.2240 Cell and tissue culture supplies and equipment
§ 864.2240 Cell and tissue culture supplies and equipment.
(a) Identification. Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.
(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. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[45 FR 60584, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]