Antigen, Antiserum, Control, Antithrombin Iii
This is an immunological reagent kit for detecting antithrombin III (now called antithrombin), the primary serine protease inhibitor of the coagulation cascade that inactivates thrombin and factor Xa, including antigen, antiserum, and control components for use in hematology laboratory immunoassays. Antithrombin III deficiency is associated with increased thrombotic risk. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDQ, regulated under 21 CFR 864.7060, within the Hematology specialty.
Basic Information
- Product Code
- DDQ
- Device Class
- FDA class 2
- Regulation Number
- 864.7060
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | Oct 20, 1997 | Substantially Equivalent | Crestat Diagnostics, Inc. |
| K935307 | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | Nov 22, 1994 | Substantially Equivalent | Baxter Diagnostics, Inc. |
| K932713 | TRACE TRANSFERRIN REAGENT | Sep 30, 1993 | Substantially Equivalent | Trace Scientific , Ltd. |
| K780012 | ANTITHROMBIN III RIA | Jan 20, 1978 | Substantially Equivalent | Ria Diagnostics |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.