Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- 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
- DEPLambda, Peroxidase, Antigen, Antiserum, Control2Product Code
- DEYIgm, Peroxidase, Antigen, Antiserum, Control2Product Code
- DFDKappa, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGHIgd, Peroxidase, Antigen, Antiserum, Control2Product Code
- DAAIgg, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGOIge, Peroxidase, Antigen, Antiserum, Control2Product Code
- DHFD/Km-1, Antigen, Antiserum, Control1Product Code
- LYECytokeratins2Product Code
- NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection2Product Code
- PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection2Product Code
- PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection2Product Code
- PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System2Product Code
- 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
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
D/Km-1, Antigen, Antiserum, Control
- Page Type
- Product Code
- Regulation Medical Specialty
- Immunology
- Review Panel
- Pathology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 866.5065
- 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 § 866.5065 Human allotypic marker immunological test system
§ 866.5065 Human allotypic marker immunological test system.
(a) Identification. A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2 m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.
(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 § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]