Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- IEOProcessor, Tissue, Automated1Product Code
- IFBCytocentrifuge1Product Code
- IBJLight, Microscope1Product Code
- IBKMicroscope, Fluorescence/U.V.1Product Code
- IBLMicroscope, Inverted Stage, Tissue Culture1Product Code
- IBMMicroscope, Phase Contrast1Product Code
- IDLMicrotome, Accessories1Product Code
- IDMMicrotome, Ultra1Product Code
- IDNMicrotome, Freezing Attachment1Product Code
- IDOMicrotome, Rotary1Product Code
- IDPMicrotome, Cryostat1Product Code
- IDQInfiltrator1Product Code
- IDROvens, Paraffin1Product Code
- IDSMelting Pot, Paraffin1Product Code
- IDTApparatus, Melting Point, Paraffin1Product Code
- IDWDispensers, Paraffin1Product Code
- IDXSieves, Tissue1Product Code
- IDYBath, Flotation, Tissue1Product Code
- IDZCassettes, Tissue1Product Code
- IEGTable, Slide Warming1Product Code
- IEHLamps, Slide Warming1Product Code
- IHJBlender, Sputum1Product Code
- KDTContainer, Specimen Mailer And Storage, Sterile1Product Code
- KDWContainer, Specimen Mailer And Storage, Temperature Controlled, Sterile1Product Code
- KDZDevice, Decalcifier, Electrolytic1Product Code
- KEGLamps, Microscope1Product Code
- KEHMicrometers, Microscope1Product Code
- KEICondensers, Microscope1Product Code
- KEJStages, Microscope1Product Code
- KERContainer, Embedding1Product Code
- KESCoverslips, Microscope Slide1Product Code
- KETFilters, Cell Collection, Tissue Processing1Product Code
- KEWSlides, Microscope1Product Code
- KEYStainer, Tissue, Automated1Product Code
- KFLMicrotome, Sliding1Product Code
- KIMDevice For Sealing Microsections1Product Code
- KINSlide Stainer, Contact Type1Product Code
- KIOSlide Stainer, Immersion Type1Product Code
- KJGTube, Tissue Culture1Product Code
- KPASlide Stainer, Automated1Product Code
- LECGrinder, Tissue1Product Code
- MJISpecimen/Tissue, Identification Orientation1Product Code
- NNKContainer, Specimen Mailer And Storage, Non-Sterile1Product Code
- NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile1Product Code
- PSYWhole Slide Imaging System2Product Code
- PZZDigital Pathology Display2Product Code
- QKQDigital Pathology Image Viewing And Management Software2Product Code
- QPNSoftware Algorithm Device To Assist Users In Digital Pathology2Product Code
- 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
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- UnknownReview Panel
Container, Specimen Mailer And Storage, Non-Sterile
- Page Type
- Product Code
- Regulation Medical Specialty
- Pathology
- Review Panel
- Pathology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 864.3250
- 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 § 864.3250 Specimen transport and storage container
§ 864.3250 Specimen transport and storage container.
(a) Identification. A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9. If the device is not labeled or otherwise represented as sterile, it is 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 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
[54 FR 47206, Nov. 13, 1989, as amended at 65 FR 2310, Jan. 14, 2000; 65 FR 18234, Apr. 7, 2000]