SPQ Antibody Reagent Set II for HPT
510(k) K890562
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890562 | Date22 Feb 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Spq(Tm) Antibody Reagent Set II for Hpt
- 510(k) Number
- FDA Product Code
- DAD
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5460
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SPQ Antibody Reagent Set II for HPT is an Antigen, Antiserum, and Control reagent set used in immunology testing. It comprises components for detecting haptoglobin, a protein involved in hemoglobin binding and immune response evaluation. Designed as a diagnostic aid, this set facilitates laboratory assays to identify and quantify haptoglobin levels in patient samples, supporting diagnostic workflows in clinical immunology.
This reagent set is supplied as a multi-component kit for in vitro use in clinical laboratories. It is intended for single-use and requires proper storage under controlled conditions to maintain stability. The device is classified under FDA 510(k) clearance (K890562) and falls under Device Class II (DAD) regulatory category, adhering to 866.5460 standards. No MRI safety or reusable specifications are noted in the regulatory filing.