SeraQuest EB VCA M
SeraQuest EB VCA M (Q01-480) is a Class I device made by Quest International, Inc., listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00850487007418), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850487007418 | Date31 Aug 2016 | StatusListed |
Official records
- AccessGUDID record 00850487007418
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- SeraQuest
- Generic name
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- EB VCA M, Q01-480
- Primary DI / UDI-DI
- 00850487007418
- FDA product code
- LJN
- GMDN term
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class I
- Regulation number
- 866.3235
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LJN (Antibody Igm, If, Epstein-Barr Virus).
- IMMUNOWELL VCA IGM TEST by Genbio
- EBV-VCA IGM ELISA by Pharmacia Diagnostics, Inc.
- SERAQUEST EB VAC IGM by Quest Intl., Inc.
- AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST by Amico Laboratories, Inc.
- MODIFICATION TO SERAQUEST VCA IGM by Quest Intl., Inc.
- EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) by IMMUNO CONCEPTS INC
- ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM by ZEUS SCIENTIFIC, INC.
- PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M by Focus Diagnostics, Inc.
- BARTELS EPSTEIN-BARR VIRUS IGM EIA by Baxter Diagnostics, Inc.
- (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM by Granbio, Inc.