DBT · Factor Xiii A, S, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5330 · Class 1
Overview
| Product Code | DBT |
|---|---|
| Device Name | Factor Xiii A, S, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5330 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872230 | MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE | Intermedics, Inc. | Sep 15, 1987 | SESE |
Top Applicants
- Intermedics, Inc. — 1 clearance
