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
- GKFInstrument, Hematocrit, Automated2Product Code
- GKHApparatus, Automated Blood Cell Diluting1Product Code
- GKJSpinner, Slide, Automated1Product Code
- GKLCounter, Cell, Automated (Particle Counter)2Product Code
- GKNTimer, Clot, Automated2Product Code
- GIZPlasma, Control, Normal2Product Code
- GKBDevice, Automated Sedimentation Rate1Product Code
- GGCControl, Plasma, Abnormal2Product Code
- GGNPlasma, Coagulation Control2Product Code
- GHKCentrifuge, Microsedimentation1Product Code
- GHRReagent, Platelet Aggregation2Product Code
- GIEFibrometer2Product Code
- GKPInstrument, Coagulation, Automated2Product Code
- GKRSystem, Hemoglobin, Automated2Product Code
- GKXInstrument, Automated Platelet Counting2Product Code
- GKZCounter, Differential Cell2Product Code
- JBTTimer, Coagulation2Product Code
- JBWRed-Cell Indices, Measured2Product Code
- JOXAnalyzer, Heparin, Automated2Product Code
- JOYDevice, Automated Cell-Locating2Product Code
- JOZSystem, Automated Platelet Aggregation2Product Code
- JPASystem, Multipurpose For In Vitro Coagulation Studies2Product Code
- JPJRed-Cell Indices, Calculated2Product Code
- JWODevice, Blood Volume Measuring2Product Code
- KQGInstrument, Coagulation2Product Code
- KQHRed-Cell Indices2Product Code
- LGPAssay, Alpha-2-Antiplasmin2Product Code
- LKMCounter, Urine Particle2Product Code
- LLGKit, Igg, Platelet Associated2Product Code
- MAMDna-Probe, B And T Lymphocyte2Product Code
- OBW11-Dehydro Thromboxane B2 Kit, Urinary2Product Code
- OYEFlow Cytometric Reagents And Accessories.2Product Code
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System2Product Code
- POVSemen Analysis Device2Product Code
- 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
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
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- UnknownReview Panel
11-Dehydro Thromboxane B2 Kit, Urinary
- Page Type
- Product Code
- Definition
- The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.
- Physical State
- n/a
- Technical Method
- An enzyme linked immunosorbent assay (ELISA) for the detection of 11dhTxB2.
- Target Area
- n/a
- Regulation Medical Specialty
- Hematology
- Review Panel
- Hematology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.5700
- 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 § 864.5700 Automated platelet aggregation system
§ 864.5700 Automated platelet aggregation system.
(a) Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
(b) Classification. Class II (performance standards).
[45 FR 60602, Sept. 12, 1980]