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- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- 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
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Quality Control For Molecular Immunohematology Tests
- Page Type
- Product Code
- Definition
- The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.
- Physical State
- DNA or synthetic plasmids
- Technical Method
- Molecular
- Target Area
- N/A
- Regulation Medical Specialty
- Hematology
- Review Panel
- Pathology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.9650
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 864.9650 Quality control kit for blood banking reagents
§ 864.9650 Quality control kit for blood banking reagents.
(a) Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.
(b) Classification. Class II (performance standards).
[45 FR 60649, Sept. 12, 1980]