Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- BSAWarmer, Blood, Electromagnetic Radiation3Product Code
- BSBWarmer, Blood, Non-Electromagnetic Radiation2Product Code
- GKTSeparator, Automated, Blood Cell, Diagnostic2Product Code
- KSBSet, Transfer (Blood/Plasma)2Product Code
- KSDDevice, Heat-Sealing1Product Code
- KSERefrigerator, Freezer, Blood Storage2Product Code
- KSFKit, Quality Control For Blood Banking Reagents2Product Code
- KSGMedia, Potentiating For In Vitro Diagnostic Use2Product Code
- KSHChamber, Environmental For The Storage Of Platelet Concentrate2Product Code
- KSILectins And Protectins2Product Code
- KSKSolution, Stabilized Enzyme2Product Code
- KSLSolution, Copper Sulfate For Specific Gravity Determinations1Product Code
- KSMSystem, Test, Combs, Automated2Product Code
- KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology2Product Code
- KSOCentrifuge, Blood-Bank For In Vitro Diagnostic Use1Product Code
- KSPApparatus, Cell-Freezing And Reagents1Product Code
- KSQDevice, Blood Mixing And Blood Weighing1Product Code
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components2Product Code
- KSSSupplies, Blood-Bank1Product Code
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual1Product Code
- KSWSystem, Processing For Frozen Blood2Product Code
- KSXSubstance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use2Product Code
- KSYBoxes, View, Blood Grouping1Product Code
- KSZSystem, Test, Automated Blood Grouping And Antibody2Product Code
- KZLDevice, Warming. Blood And Plasma2Product Code
- MMHBlood Establishment Computer Software And Accessories2Product Code
- MYJDevice, Mixing And Weighing, Semi-Automated2Product Code
- MYXSystem, Blood Collection, Vacuum-Assisted, Automated1Product Code
- OQXSelf-Contained Blood Grouping2Product Code
- ORGPlatelet And Plasma Separator For Bone Graft Handling2Product Code
- PBCManual Blood Grouping And Antibody Test Systems2Product Code
- PKGBone Marrow Processing Device To Support Hematopoietic Reconstitution2Product Code
- PMQPeripheral Blood Processing Device For Wound Management2Product Code
- QYCContainer System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions2Product Code
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
System, Test, Combs, Automated
- Page Type
- Product Code
- Regulation Medical Specialty
- Hematology
- Review Panel
- Hematology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.9300
- 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 § 864.9300 Automated Coombs test systems
§ 864.9300 Automated Coombs test systems.
(a) Identification. An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.
(b) Classification. Class II (performance standards).
[45 FR 60646, Sept. 12, 1980]