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
- DBTFactor Xiii A, S, Antigen, Antiserum, Control1Product Code
- DDECarbonic Anhydrase C, Antigen, Antiserum, Control1Product Code
- DDFProthrombin, Antigen, Antiserum, Control1Product Code
- DDHCarbonic Anhydrase B, Antigen, Antiserum, Control1Product Code
- DDXPlasminogen, Antigen, Antiserum, Control1Product Code
- DGBSeminal Fluid, Antigen, Antiserum, Control1Product Code
- DGQWhole Blood Plasma, Antigen, Antiserum, Control1Product Code
- DGRWhole Human Serum, Antigen, Antiserum, Control1Product Code
- KTKReagent, Immunoassay, Carbonic Anhydrase B And C1Product Code
- MVSKit, Typing, Hla-Dqb2Product Code
- 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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Factor Xiii A, S, Antigen, Antiserum, Control
- Page Type
- Product Code
- Regulation Medical Specialty
- Immunology
- Review Panel
- Hematology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 866.5330
- 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 § 866.5330 Factor XIII, A, S, immunological test system
§ 866.5330 Factor XIII, A, S, immunological test system.
(a) Identification. A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.
(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. This exemption does not apply to factor deficiency tests classified under § 864.7290 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]