Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- OYTBlood Establishment Computer Software, User DevelopedUProduct Code
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- QHRBlood Grouping ReagentUProduct Code
- QHSAnti-Human GlobulinUProduct Code
- QHTReagent Red Blood CellsUProduct Code
- KSJSystem, Identification, Hepatitis B Antigen3Product Code
- MTHTray, Leukocyte TypingNProduct Code
- MTKKit, Sample Collection, Hiv3Product Code
- MTLMonitor,Test,Hiv-13Product Code
- MTNTest, Syphilis, TreponemalNProduct Code
- MTOSoftware, Management, Microplate AssayNProduct Code
- MTPAntibody To Htlv-1, Elisa3Product Code
- MTQSoftware, Blood Virus ApplicationsNProduct Code
- MTRProgenitor Cell Enumeration2Product Code
- MTSVials, Challenge, EndotoxinNProduct Code
- MVWKit, Western Blot, Hiv-1NProduct Code
- MVXAntibody, Monoclonal Blocking, Hiv-1NProduct Code
- MVYMonoclonal, Hiv-1NProduct Code
- MVZSystem, Test, Home, Hiv-13Product Code
- MWBKit, Test, Saliva, Hiv-1&23Product Code
- MWOReagent, Blood Bank, Quality ControlNProduct Code
- MYKKit, Cord Blood CollectionNProduct Code
- MYPTest, Platelet Antibody2Product Code
- MYQKit, Antibody, ElutionNProduct Code
- MYSDevice, Ahf, Automated CryoprecipitationNProduct Code
- MYWIrradiation, Blood IndicatorsNProduct Code
- MYYSeparator, Semi-Automated, Blood Component1Product Code
- MZHTest, Quantitative, For Hla, Non-DiagnosticNProduct Code
- MZITest, Qualitative, For Hla, Non-DiagnosticUProduct Code
- MZJSystem, Concentration, Hematopoietic Stem Cell3Product Code
- MZKSystem, Separation, Hematopoietic Stem Cell3Product Code
- NDVTest, Ecarin Clotting Time (Ect)FProduct Code
- OTQResearch Use Only/Hematology DevicesNProduct Code
- OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)FProduct Code
- PBAEcarin Clotting TimeFProduct Code
- PCZInvestigational Use Only - ImmunologyNProduct Code
- PDCInvestigational Use Only - HematologyNProduct Code
- PEPMolecular Erythrocyte Typing Test3Product Code
- PJFIlluminator System For Blood Products3Product Code
- PZTPeripheral Blood Processing Device For OsteoarthritisNProduct Code
- PZUBone Marrow Processing Device For Clinical UseNProduct Code
- PZVPeripheral Blood Processing Device For Clinical UseNProduct Code
- QBGAssay, Oral Direct Thrombin InhibitorNProduct Code
- QCZMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator3Product Code
- QPWReagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection TubeNProduct Code
- QTYVon Willebrand Factor Assay2Product Code
- QWYMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator3Product Code
- SACAdamts13 Activity Test System2Product Code
- QZVPediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury3Product Code
- SALDevice, Automated Cell Locating, Bone Marrow3Product Code
- SCKLdt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative IvdNProduct Code
- Submissions with No Product CodeMiscellaneous
- 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
- 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
Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
- Page Type
- Product Code
- Definition
- Non-molecular antisera laboratory developed tests (LDTs) for rare red blood cell (RBC) antigens when manufactured and performed by blood establishments, including transfusion services and immunohematology laboratories, and when there is no alternative in vitro diagnostic product (IVD) available to meet the patient's need for a compatible blood transfusion within the scope described in Section V.B.3 of the preamble to the Final LDT Rule (89 FR 37286).
- Physical State
- In vitro diagnostic device
- Technical Method
- In vitro diagnostic device
- Target Area
- In vitro diagnostic device
- Review Panel
- Hematology
- Submission Type
- Enforcement Discretion
- Device Classification
- N
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
As product code SCK is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.