Factor VIII Antibody Screen
510(k) K082205
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082205 | Date20 Nov 2008 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- GGP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7290
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Factor VIII Antibody Screen is a diagnostic test used to detect IgG antibodies against recombinant human Factor VIII. It is an ELISA-based kit that utilizes a 96-well microwell plate coated with recombinant FVIII.
The device is used in clinical laboratories with patient serum or plasma samples. It is supplied as a kit for in vitro diagnostic use and is classified under hematology specialty. Authorizations include FDA 510(k) clearance (K082205).
Other devices from Genetic Testing Institute
Questions
AI-generated answers, 22 Sep 2026
What is the Factor VIII Antibody Screen used for?
The Factor VIII Antibody Screen is used to detect IgG antibodies against recombinant human Factor VIII in patient serum or plasma samples, aiding in the diagnosis of immune responses to Factor VIII in hematology testing.
How is the Factor VIII Antibody Screen supplied and what type of test is it?
The Factor VIII Antibody Screen is supplied as an ELISA-based kit in a 96-well microwell plate format coated with recombinant FVIII, designed for in vitro diagnostic use in clinical laboratories.
Is the Factor VIII Antibody Screen a single-use or reusable device?
The Factor VIII Antibody Screen is intended for single-use as an in vitro diagnostic kit; each test requires a fresh sample and the reagents are not designed for reuse after initial testing.